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 |
|---|---|---|
| HEAD-IMMOBILIZER (K832001) | Int'L Safety Corp. | 1983-07-12 |
| STRYKER LEG EXERCISER (K831910) | Stryker Corp. | 1983-07-12 |
| MICRO SURGICAL HANDLE (K831996) | Visitec Co. | 1983-07-12 |
| SURGICAL APPAREL SHOE COVERS (K831952) | Sudreca Surgical Dressings, Inc. | 1983-07-12 |
| SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (K822411) | Western Advanced Technology, Inc. | 1983-07-12 |
| LEATHER VALVE CUTTER (K831455) | American V. Mueller | 1983-07-07 |
| RIONET HEARING AID -AND/OR RION (K831721) | Rion Acoustic Instruments, Inc. | 1983-07-07 |
| MICRO-AIRE REPLACEMENT SURG. SAW BLADE (K831714) | Micro-Aire Surgical Instruments, Inc. | 1983-07-07 |
| SURGEON'S CHOICE CRUTCH HANDLE (K831889) | W.K. Wheeler, Inc. | 1983-07-07 |
| ELECTROPHORESIS CONTROLS-3 IN 1 (K831263) | Corning Medical & Scientific | 1983-07-07 |
| SURGICAL DRILL BITS (K831712) | Medical Specialists IN Packaging | 1983-07-07 |
| NON CONDUCTIVE ANESTHESIA FACEMASK (K831713) | Vital Signs, Inc. | 1983-07-07 |
| CHLAMYDIA OVERBY MEDIA (K831686) | Viromed Laboratories, Inc. | 1983-07-07 |
| SUPPORT PRODUCTS EXAMPLE PROSET CAST (K830650) | Isopedix Corp. | 1983-07-07 |
| GUILLOTINE BLADE (K831772) | Ortho Pared Instruments, Inc. | 1983-07-07 |
| ENSWELL (K831899) | Dr. Micheal A. Sabia | 1983-07-07 |
| GUM MACHINE (K831321) | The Gum Machine Co. | 1983-07-07 |
| TITAN GE/IEPLATE (K831603) | Helena Laboratories | 1983-07-07 |
| HEP-2 CELLS (K831681) | Viromed Laboratories, Inc. | 1983-07-06 |
| PENTOBARBITAL TOXICOLOGY CONTROL (K831739) | Utak Laboratories, Inc. | 1983-07-06 |
| CYNOMOLGUS MONKEY KIDNEY CELLS SV5 (K831684) | Viromed Laboratories, Inc. | 1983-07-06 |
| SF REFEEDING MEDIA (K831685) | Viromed Laboratories, Inc. | 1983-07-06 |
| VERO CELLS (K831680) | Viromed Laboratories, Inc. | 1983-07-06 |
| MCCOY CELLS (K831682) | Viromed Laboratories, Inc. | 1983-07-06 |
| SF CELLS (K831683) | Viromed Laboratories, Inc. | 1983-07-06 |
| BASAL MEDIUM EAGLE W/EARLES SALTS, & (K831745) | Sigma Chemical Co. | 1983-07-06 |
| MRC-5 CELLS (K831679) | Viromed Laboratories, Inc. | 1983-07-06 |
| DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE (K831740) | Utak Laboratories, Inc. | 1983-07-06 |
| TRI-LEVEL TDM CONTROL & I II III (K831500) | Ortho Diagnostic Systems, Inc. | 1983-06-30 |
| INFUSION CANNULA (K831192) | Medical Instrument Development Laboratories, Inc. | 1983-06-30 |
| TRULIFE SILICONE BREAST FORM (K831831) | Medeering, Ltd. | 1983-06-30 |
| RELIANCE TEMPO OPHTH. INSTR STAND (K831568) | F. & F. Koenigkramer | 1983-06-30 |
| ROTOR (K831571) | American Scientific Products | 1983-06-30 |
| SPECIFIC GRAVITY INSTRUMENT (K831213) | Iris | 1983-06-30 |
| HEMATOLOGY PAK (K831605) | Mercedes Scientific Co., Inc. | 1983-06-30 |
| SUN PHOTO-KERATOSCOPE (K831084) | Nidek, Inc. | 1983-06-30 |
| RARE-EARTH INTRA-OCULAR MAGNET (K831702) | Miami Eye Technology, Inc. | 1983-06-30 |
| AUDIOSCOPE #23000 W/71123 CHARGING STAND (K831709) | Welch Allyn, Inc. | 1983-06-30 |
| TWIST LOCK DRILL 1120 (K831675) | Micro-Aire Surgical Instruments, Inc. | 1983-06-30 |
| RIM-CAMP TEST (K831674) | Austin Biological Laboratories | 1983-06-30 |
| CUSTOM IN-THE-EAR HEARING AID (K830960) | Finetone Hearing Instruments | 1983-06-30 |
| REAGENT CUPS (K831569) | American Scientific Products | 1983-06-30 |
| ARM SLINGS (K831549) | Fred Sammons, Inc. | 1983-06-30 |
| YESONA PLASTER OF PARIS BANDAGE (K831492) | Watson Phillips Y Cia. Sucs., S.A. DE C.V. | 1983-06-30 |
| DENTURE ADHESIVE SEALS (K831493) | Johnson & Johnson Professionals, Inc. | 1983-06-30 |
| OXY-SWAB (K831673) | Austin Biological Laboratories | 1983-06-30 |
| SPLINTS (K831548) | Fred Sammons, Inc. | 1983-06-27 |
| TPG 1000 (K831002) | Physical Diagnostics, Inc. | 1983-06-24 |
| ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (K831543) | Fred Sammons, Inc. | 1983-06-24 |
| TLS SURGICAL MARKER (K831372) | Porex Medical | 1983-06-24 |
| SITZ BATH, SINGLE PATIENT USE #8100 (K831762) | Lsl Industries, Inc. | 1983-06-24 |
| SATO FAMILY FIRST AID KIT (K831706) | Food and Drug Service, Inc. | 1983-06-24 |
| DELUXE TRACTION EXERCISE GLOVE BK5035 (K831544) | Fred Sammons, Inc. | 1983-06-24 |
| IPOS ANTI-ADDUCTUS SHOE (K831690) | Ipos Luneburg | 1983-06-24 |
| FINGER BONIOMETER BK7506 (K831550) | Fred Sammons, Inc. | 1983-06-24 |
| ADJUSTABLE POLYCENTRIC ELBOW HINGE (K831542) | Fred Sammons, Inc. | 1983-06-24 |
| LIMITED MOTION FUNCTIONAL KNEE BRACE (K831044) | Orthopedic Systems, Inc. | 1983-06-24 |
| SAUNDERS #7080 CERVICAL TRACTION SYS (K831135) | Chattanooga Group, Inc. | 1983-06-24 |
| SAGITTAL KNEE TESTER (K831041) | Orthopedic Systems, Inc. | 1983-06-24 |
| STRAITH ORAL AIRWAY (K831078) | Surgical Technology Laboratories, Inc. | 1983-06-24 |
| AUTO CAROUSE/WASH SOLUTION CONCENTRATE (K831518) | Syva Co. | 1983-06-22 |
| BLOOD GAS & FLAME PHOTOMETER INSTRU- (K831075) | United Diagnostics, Inc. | 1983-06-22 |
| SPECTRUM-10 (K831672) | Austin Biological Laboratories | 1983-06-22 |
| RIM BETA LACTAMASE TEST (K831654) | Austin Biological Laboratories | 1983-06-22 |
| RPMI-1640 MEDIUM W/L-GLUTAMINE & (K831519) | Sigma Chemical Co. | 1983-06-22 |
| ORTHO WRAP (K830622) | Fast Wrap Co., Inc. | 1983-06-20 |
| UNI-THANE (K831611) | Carapac Systems, Inc. | 1983-06-20 |
| PARAFFIN INFILTRATION MEDIUM (K831580) | Surgipath Medical Industries, Inc. | 1983-06-17 |
| YELLOW IRIS TM (K830220) | Intl. Remote Imaging Systems | 1983-06-17 |
| SPECTRUM-10 (K831655) | Austin Biological Laboratories | 1983-06-17 |
| GLUCOSE 3, INLAB REAGENT STRIPS-URINALY (K831499) | Laprol Scientific, Inc. | 1983-06-17 |
| DEMAND ANALYZER SYSTEM (K831477) | Worthington Diagnostic Systems | 1983-06-17 |
| GONORRHEA TRANSETTE 1 & 3 (K831579) | Spectrum Diagnostic, Inc. | 1983-06-17 |
| PATIENT GUIDED ELBOW & SHOULDER EXERC (K830793) | Richard'S Medical Equip., Inc. | 1983-06-16 |
| MODIFIED UNSCENTED MENSTRUAL PADS (K831707) | Personal Products Co. | 1983-06-16 |
| PREFILLED IEC COLUMNS (K831289) | Berwick Medical Products, Inc. | 1983-06-16 |
| ANHYDRIC INCUBATORS, CULTURE INCUBATOR (K831592) | Boekel Industries, Inc. | 1983-06-16 |
| GRAF MENISCAL SUTURE SET (K830720) | Acufex Microsurgical, Inc. | 1983-06-16 |
| VENT TUBE FORCEPS (K831589) | Treace Medical, Inc. | 1983-06-16 |
| E-Z PREP (K831558) | Coulter Electronics, Inc. | 1983-06-16 |
| ASO-CHECK (K831464) | Diagnostic Technology, Inc. | 1983-06-16 |
| DILUENT (K831617) | Omega Medical Diagnostics | 1983-06-16 |
| RAPID IDENTIFI-METHOD NEISSERIA KIT (K830968) | Austin Biological Laboratories | 1983-06-16 |
| EMIT QST TOBRAMYCIN CONTROL (K831417) | Syva Co. | 1983-06-16 |
| DROP FOOT BRACE (K831615) | Edward Dilauro, Jr. | 1983-06-15 |
| T-TUBE INSERTER (K831590) | Treace Medical, Inc. | 1983-06-15 |
| VARI-SUPPORT NECK POSTURE PILLOW (K831582) | Body Therapeutics, Inc. | 1983-06-15 |
| URINE SCREENING KIT (K830824) | Syn-Kit, Inc. | 1983-06-12 |
| ETHICON EXTERNAL FIXATION WIRE (K821178) | ETHICON, Inc. | 1983-06-11 |
| MICROSURGICAL KNIFE (K831266) | Vxtra Corp. | 1983-06-10 |
| LENSERT CONTACT LENS CLEANING & INSERT (K830738) | Jermyn Specialties of California | 1983-06-10 |
| AUTO REFRACTOMETER (K831083) | Nidek, Inc. | 1983-06-10 |
| NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE (K831476) | Fls Medical Products, Inc. | 1983-06-10 |
| EYELID SPECULUM (K830430) | Douglas C. Mckee & Co. | 1983-06-10 |
| REACHER & DOOR OPENER (K831545) | Fred Sammons, Inc. | 1983-06-08 |
| SECTIONING AID KIT (K831065) | Technicon Instruments Corp. | 1983-06-08 |
| SORBOTHANE VISCO INNER SOLE PAD (K831552) | Fred Sammons, Inc. | 1983-06-08 |
| ADAPTIVE PENS & LAP DESK (K831546) | Fred Sammons, Inc. | 1983-06-08 |
| COMPRESSOGRIP ELASTIC STUMP SHRINKER# (K831540) | Fred Sammons, Inc. | 1983-06-08 |
| LINEAR ENZMATIC URIC ACID SYSTEM (K831398) | Simmler, Inc. | 1983-06-08 |
Track 1 automatically
Every clearance here is in the API, with alerts when new ones post.