1
32,815 FDA 510(k) clearances · Device class
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
| Record | Firm | Date |
|---|---|---|
| TEEN CLEAN, RETAINER CLEANER (K860737) | Teen Care, Inc. | 1986-03-26 |
| ENDODONTIC ROOT CANAL PLUGGER (K860569) | Dentsply Intl. | 1986-03-26 |
| CRAIGWELL AID HA300 (K854124) | Craigwell Electronics, Ltd. | 1986-03-26 |
| DENTAL FLOSS HOLDER (K860769) | Sewon Industry | 1986-03-26 |
| BED PATIENT MONITOR (K854950) | Clearview Electronics Corp. | 1986-03-25 |
| BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (K860648) | Precision Instruments, Inc. | 1986-03-25 |
| DIAMONDS BURS-COMPOSIT FINISHING (K854690) | Almore Intl., Inc. | 1986-03-25 |
| DENSCO PROPHY PASTE (K854829) | Scientific Pharmaceuticals, Inc. | 1986-03-25 |
| DIAMOND BURS-HANDPIECE (K854691) | Almore Intl., Inc. | 1986-03-25 |
| MEDICAL ADHESIVE TAPE (K860804) | W.R. Grace & Co.-Conn. | 1986-03-24 |
| PS2 BRAND MAMMAPLASTY (K860912) | Professional Services For Surgeons, Ltd. | 1986-03-24 |
| IV BAND (INTRAVENOUS CATHETER ASSESORY) (K860706) | T. G. & E. Medical | 1986-03-21 |
| MAZZOCCO/FRENCHIK FOLDER (K860148) | Staar Surgical Co. | 1986-03-21 |
| CIRRUS DRUG NEBULIZER MK III (K860875) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| DISPOSABLE VENTILATOR CIRCUITS (K860879) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| FLEXTUBE, CONNECTING TUBING (K860877) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (K860885) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| DISPOSABLE CATHETER (K860882) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| LARYNGEAL MIRROR PRE-WARMER (K855021) | Jedmed Instrument Co. | 1986-03-20 |
| VENTILATOR CIRCUITS (VARIOUS TYPES) (K860880) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| BRITISH BREATHING CIRCUIT SYSTEM (K860878) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| VENTURI MASK/ADULT & PAEDIATRIC (K860873) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| STRAIGHT CONNECTORS, 22MM (K860886) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (K860874) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| MEDIUM CONCENTRATION OXYGEN MASKS (K860869) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| SELF-SEALING WATER TRAP/ACCESSORIES (K860884) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| AESCULAP BONE MILL (K860016) | Aesculap Instruments Corp. | 1986-03-19 |
| CONNECTORS/VALVE INSERT (K860888) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC (K860871) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS (K860883) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| ACROMED SPINAL SURGERY INSTRUMENTS (K860131) | Buckman Co., Inc. | 1986-03-19 |
| CATHETER MOUNTS & ELBOWS (VARIOUS TYPES) (K860881) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| T-PIECES CONNECTORS (K860887) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014 (K860352) | Spacelabs, Inc. | 1986-03-19 |
| NASAL CANNULA W/2M & 5M TUBING (K860872) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| AEROSOL MASKS/ADULT & PAEDIATRIC (K860870) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-19 |
| CAMCO STAIN PAK (K860793) | Cambridge Chemical Products, Inc. | 1986-03-18 |
| CAMPYLOBACTER CVA AGAR (K860862) | Gibco Laboratories Life Technologies, Inc. | 1986-03-18 |
| UNICADDY I & II I.V. CONTAINER CADDY IMS POLE MATE (K860468) | Intl. Medication Systems, Ltd. | 1986-03-18 |
| THE WOOD PUMP 'OLE RED' (K855054) | T.C. Retigo, Inc. | 1986-03-18 |
| PRESSURE INFUSOR #1900 (K860084) | Pa Medical Corp. | 1986-03-18 |
| DIFCO STREP A LATEX TEST (K854978) | Difco Laboratories, Inc. | 1986-03-18 |
| SIMULATOR (K854265) | Cygnus of South Florida, Inc. | 1986-03-18 |
| ROOT CANAL ORGANIZER (K860817) | Pacific Union Dental, Inc. | 1986-03-17 |
| SERIES 410 LC PUMP (K860197) | The Perkin-Elmer Corp. | 1986-03-17 |
| TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS (K860690) | Catachem, Inc. | 1986-03-17 |
| BOVINE CHEMISTRY CONTROL I.X AND II.X (K860355) | American Dade | 1986-03-17 |
| CALIBRATION REFERENCE I & II (K855035) | Integrated Medical Systems Int'L., Inc. | 1986-03-17 |
| MODEL 353C HEARING AID (K860035) | Telex Communications, Inc. | 1986-03-17 |
| SUCROSEP LUTEINIZING HORMONE (LH) IRMA (K860308) | Boots-Celltech Diagnostics, Inc. | 1986-03-17 |
| HURWITZ AMNIOCENTESIS NEEDLE (K854725) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-03-17 |
| LEECO TESTOSTERONE DIAGNOSTIC KIT (K860003) | Leeco Diagnostics, Inc. | 1986-03-17 |
| CHEMISTRY CONTROL N & A (K855036) | Integrated Medical Systems Int'L., Inc. | 1986-03-17 |
| GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET (K860348) | Sterling Diagnostics, Inc. | 1986-03-17 |
| TELESTAR I, HEARING AID (K860512) | The Florida Hearing Aid Service | 1986-03-17 |
| PRIMADERM (K854740) | Absorbent Cotton Co., Inc. | 1986-03-14 |
| SOLAR (K854643) | Alpine Dental Equipment Co. | 1986-03-14 |
| MCBRIDE LISTERIA AGAR (K860861) | Gibco Laboratories Life Technologies, Inc. | 1986-03-14 |
| SERUM IRON & IRON BINDING REAGENT SET (K860478) | Sterling Diagnostics, Inc. | 1986-03-14 |
| SERUM LIPASE REAGENT SET (TURBIDIMETRIC) (K860554) | Sterling Diagnostics, Inc. | 1986-03-14 |
| SOLAR CART (K854642) | Alpine Dental Equipment Co. | 1986-03-14 |
| CAT-3 CATECHOLAMINE ASSAY KIT (K855214) | Whale Scientific, Inc. | 1986-03-14 |
| ANDROSTENEDIONE 125I KIT BY RIA (K860559) | Immuchem Corp. | 1986-03-14 |
| INORGANIC PHOSPHORUS REAGENT SET (K860628) | Sterling Diagnostics, Inc. | 1986-03-14 |
| HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK (K860294) | I.C.D. Industries, Inc. | 1986-03-13 |
| TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (K854168) | Travenol Laboratories, S.A. | 1986-03-13 |
| RESPIRONICS SECUREASY (K860845) | Respironics, Inc. | 1986-03-13 |
| KOTEX OVERNITE (K860587) | Kimberly-Clark Corp. | 1986-03-13 |
| THE POREX RETRACTOR TABLE (K860503) | Porex Medical | 1986-03-13 |
| MEDICAL X-RAY FILM (K860797) | India-America Trading Co. | 1986-03-13 |
| SPOTTEST CALCOFLUOR WHITE REAGENT (K860795) | Difco Laboratories, Inc. | 1986-03-12 |
| A & M DISCREET - HEARING AID (K860190) | Electone, Inc. | 1986-03-12 |
| DULBECCO'S MEM (K860787) | Tissue Culture Innovations | 1986-03-12 |
| DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (K860784) | Tissue Culture Innovations | 1986-03-12 |
| GOLD AIR, GOLD LIGHT (K854645) | Alpine Dental Equipment Co. | 1986-03-12 |
| RPMI 1640 HEPES (K860786) | Tissue Culture Innovations | 1986-03-12 |
| A & M 150 PP (HEARING AID) (K860244) | Electone, Inc. | 1986-03-12 |
| HAM'S F-12 W/NAHCO3 (K860785) | Tissue Culture Innovations | 1986-03-12 |
| DENPAX (K860058) | Nissho Iwai American Corp. | 1986-03-12 |
| MICRO CARRIER (K860783) | Tissue Culture Innovations | 1986-03-12 |
| PA PRESIDENTIAL II - HEARING AID (K860191) | Electone, Inc. | 1986-03-12 |
| AM 12, HEARING AID (K860007) | Electone, Inc. | 1986-03-12 |
| HAM'S F-12 W/GLUTAMINE & NAHCO3 (K860788) | Tissue Culture Innovations | 1986-03-12 |
| BEHIND THE EAR HEARING AIDS MODEL (K855240) | Bernafon, Inc. | 1986-03-12 |
| GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) (K860695) | Gibco Laboratories Life Technologies, Inc. | 1986-03-12 |
| AM 31, HEARING AID (K860008) | Electone, Inc. | 1986-03-12 |
| S.T.P.B SOFT TISSUES PROTECTIVES BLADES (K854467) | Nortex USA, Inc. | 1986-03-12 |
| CURITY FIBEROPTIC INTUBATING AIRWAY (K855137) | The Kendal Co. | 1986-03-11 |
| OXOID STREPTOCOCAL GROUPING KIT (K854929) | Oxoid U.S.A., Inc. | 1986-03-11 |
| DIFFERENTIATION DISKS VANCOMYCIN 5 MCG (K860563) | Difco Laboratories, Inc. | 1986-03-11 |
| RESPIRATORY RESUSCITATION DEVICE (K854029) | John H. Harrison | 1986-03-11 |
| DIFFERENTIATION DISKS PENICILLIN G 2 UNITS (K860561) | Difco Laboratories, Inc. | 1986-03-11 |
| AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT (K855034) | Bartels Immunodiagnostic Supplies, Inc. | 1986-03-11 |
| DIFFERENTIATION DISKS KANAMYCIN 1000 MCG (K860565) | Difco Laboratories, Inc. | 1986-03-11 |
| DIFFERENTIATION DISKS RIFAMPIN 15 MCG (K860560) | Difco Laboratories, Inc. | 1986-03-11 |
| NEISSERIASTAT (K860156) | Richardson Scientific, Inc. | 1986-03-11 |
| OFPBL (K860707) | Remel Co. | 1986-03-11 |
| DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG (K860564) | Difco Laboratories, Inc. | 1986-03-11 |
| DIFFERENTIATION DISKS COLISTIN 10 MCG (K860562) | Difco Laboratories, Inc. | 1986-03-11 |
| SOLAR F (K854641) | Alpine Dental Equipment Co. | 1986-03-10 |
Track 1 automatically
Every clearance here is in the API, with alerts when new ones post.