Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DRI-FORM PSEUDOMONAS AGAR F (K852064)Gibco Laboratories Life Technologies, Inc.1985-06-04
ELECTRO-CAUTERY KNIFE CLEANER 6000 1 (K852184)Dlp, Inc.1985-06-04
HEP-2 GENCELLS (K852206)Genus Diagnostics1985-06-04
SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (K850435)Sartorius Filters, Inc.1985-06-04
INCISION DRAIN (K851196)Sil-Med Corp.1985-06-04
CELLGRO (K852288)Mediatech, Inc.1985-06-04
QUALITONE STOCK CANAL AID (K851970)Qualitone1985-06-04
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (K844762)Wellcome Diagnostics1985-06-04
HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE (K851648)Heraeus Dental Gold Corp.1985-06-04
ECONOMY 400 CWS WITH PVC DRAINS (K851084)C.R. Bard, Inc.1985-06-04
LYFO-KWIK OMI KIT (K851978)Micro-Bio-Logics1985-06-04
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER (K851015)Teledyne Avionics Div. of Teledyne1985-06-04
PROSTHESIS OR SURGICAL PADS (K851668)Virginia Hall, Inc.1985-06-04
RMK GENCELLS CULTURE SYSTEM (K852205)Genus Diagnostics1985-06-04
S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP (K851421)Joint Medical Products Corp.1985-06-04
PENNINE DERBY YANKAUER (K852079)Pennine Medical , Ltd.1985-06-03
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (K852150)Keeler Instruments, Inc.1985-06-03
LINK CEMENTLESS SCREW-IN ACETABULAR CUP (K843940)Waldemar Link GmbH & Co. KG1985-06-03
INTEGRITY EYE DROP GUIDE (K851908)Integrity Optics, Inc.1985-06-03
LINK CEMENTLESS SCREW-IN ACETABULAR CUP (K843950)Waldemar Link GmbH & Co. KG1985-06-03
PENNINE SUCTION CATHETERS (K852080)Pennine Medical , Ltd.1985-06-03
AST ASPARTATE AMINOTRANSFERASE REAGENT (K851994)Alpkem Corp.1985-06-03
IP ACID REAGENT IP MOLY BDATE REAGENT (K852003)Alpkem Corp.1985-05-31
CORNEAL LIGHT SHIELD (K850270)Mentor O & O, Inc.1985-05-31
SC-360 SPECTROPHOTOMETER (K852047)Pharmacia, Inc.1985-05-31
CILCO/UNITED SONICS PHACE PF-9000 (K851209)United Sonics, Inc.1985-05-31
DELFIA HTSH KIT (K851120)Lkb Instruments, Inc.1985-05-31
OMNIMED CLAMP (K851654)Omni Intl., Inc.1985-05-31
UNITED SONICS PHACO MODULE, DF-35 (K851210)United Sonics, Inc.1985-05-31
ELECTRO-NERVE STIMULATOR DISCO B9 TENS (K851191)Biomedical Life Systems, Inc.1985-05-31
MYOMETER EMG BIOFEEDBACK DEVICE (K850849)Physio Technology, Inc.1985-05-31
ENDAB TSH (K851980)Immunotech Corp.1985-05-31
PORTASUN MODEL 600/LI SUNLAMP (K852149)Portasun , Ltd.1985-05-31
UNITED SONICS PACO SYSTEM MODEL 3000 (K851212)United Sonics, Inc.1985-05-31
EVOMATIC 8000/4000 (K843815)Dantec Electronics, Inc.1985-05-31
LD-L REAGENT (K851996)Alpkem Corp.1985-05-31
AXON II BRAND OF DUAL CHANNEL TENS (K850860)Cassandra Electronics Corp.1985-05-31
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN (K852103)Medical Analysis Systems, Inc.1985-05-31
TOTAL BILIRUBIN STANDARDS (K852068)Data Medical Associates, Inc.1985-05-31
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY (K851942)Coulter Electronics, Inc.1985-05-31
MID LABS MVSXI (K851298)United Sonics, Inc.1985-05-31
DIRECT BILIRUBEN CALIBRATIONS (K852067)Data Medical Associates, Inc.1985-05-31
CRESTLINE CB BEHIND-THE-EAR HEARING AID (K850981)Dahlberg Electronics, Inc.1985-05-31
IV/0165 INFUSION SET (K851336)Infarkem Corp.1985-05-30
PEDIATRIC IV WATCH (K852030)Alltek, Inc.1985-05-30
LD-P REAGENT (K851997)Alpkem Corp.1985-05-30
ALB BCG REAGENT (K852007)Alpkem Corp.1985-05-30
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) (K852140)North American Instrument Corp.1985-05-30
CRE BUFFER CRE DYE (K851993)Alpkem Corp.1985-05-30
T-CHO REAGENT (K852009)Alpkem Corp.1985-05-30
SOLEX & SAXON INT'L OPTICAL OF HONG KONG (K851661)South West Intl., Inc.1985-05-30
CK-NAC REAGENT (K852000)Alpkem Corp.1985-05-30
SUNGLASES (K851163)Full See Glasses Ind. Co., Ltd.1985-05-30
TGL REAGENT (K852010)Alpkem Corp.1985-05-30
I.V. WATCH (K852029)Alltek, Inc.1985-05-30
BORNING NEONATAL RESUSCITATOIN CENTER (K850069)Borning Corp.1985-05-30
SPECTACLE FRAME (K851130)New Brillette A/S1985-05-30
ALT (ALANINE AMINO-THRANSFERASE)REAGENT (K851995)Alpkem Corp.1985-05-30
ALP(ALKALINE)(PHOSPHATASE) REAGENT (K851998)Alpkem Corp.1985-05-30
37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS (K851791)Artiberia1985-05-30
ON TARGET (K851887)Newman Assoc.1985-05-30
ANESTHESIOMETER (K851557)Luneau SA1985-05-30
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL (K852008)Alpkem Corp.1985-05-30
37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS (K851792)Artiberia1985-05-30
MODEL 2000 INDULIN INFUSION PUMP (K851564)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-05-30
ENTERAL FEEDING PUMP (K851351)Empire Industries, Inc.1985-05-30
VIGGO ACCESSORIES FOR I.V. THERAPY (K850769)Viggo Products1985-05-29
UN(UREASE)REAGENT UN(A-KETO)REAGENT (K851991)Alpkem Corp.1985-05-29
IMAX PERIOTIPS (K851841)Stram Dental, Inc.1985-05-29
EARETTE HEARING AID(BEHIND THE EAR OTICON E35F (K851429)Oticon Corp.1985-05-29
HALIFAX SPINAL CLAMP (K850039)Levtech, Inc.1985-05-29
TYPE FP30 DIGITAL HEARING AID ANALYZER (K850918)Frye Electronics, Inc.1985-05-29
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC (K851126)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES (K852035)Continental Scale Corp.1985-05-29
RAKA OCH BOSDA PEANGER (K851673)General Electric Trading Co.1985-05-29
EARETTE HEARING AID(BEHIND THE EAR OTICON E37F (K851430)Oticon Corp.1985-05-29
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. (K851746)Artiberia1985-05-29
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO (K851127)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
UP800 A UNIVERSAL PRINTER (K845050)Madsen Electronics (Canada) , Ltd.1985-05-29
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK (K851125)E.I. Dupont DE Nemours & Co., Inc.1985-05-29
VERA BOND NON PERCIOUS CERAMIC ALLOY (K851569)Aalba Dent, Inc.1985-05-29
CHAMBER V-9 PLUS AGAR (K851238)Bug City Company, Inc.1985-05-29
MARUKYR-BAN / HOT OR HEAT PACK (K850566)Oriental Medical Supplies, Inc.1985-05-29
UA(URICASE) REAGENT (K852004)Alpkem Corp.1985-05-29
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT (K850666)Ipco Corp.1985-05-29
STERILE GENERAL HOSPITAL SUPPLIES (K851390)Biological & Environmental Control Laboratories1985-05-29
BACTIGEN GROUP B STREPTOCOCCUS TEST (K850772)Armkel, LLC1985-05-29
GLU(GOD) REAGENT (K851992)Alpkem Corp.1985-05-29
BP-800 (K843010)Pollenex Associated Mills, Inc.1985-05-29
SEPTOSIL SILICONE FOR PRECISION IMPRESSION (K851388)Specialites Septodont1985-05-29
LERE NAIL & PLATE COMBIN. ONE PIECE FORGED (K851349)Medicalex1985-05-29
BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 (K851547)Bernafon, Inc.1985-05-29
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER (K852027)Advanced Biomedical Methods, Inc.1985-05-29
SPACELABS-GENERAL SYSTEM LINK (K850627)Spacelabs, Inc.1985-05-28
AIR COMPRESSOR (K850795)Bear Medical Systems, Inc.1985-05-28
BFW VOICE GENERATOR (K851462)Bfw Laboratories, Inc.1985-05-28
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS (K850928)Unitas Ent.1985-05-28
ALLERGENETICS IGE FAST TEST (K851512)Allergenetics1985-05-28
SLIT CAMERA MODEL 07-624 (K851811)Victoreen, Inc.1985-05-28
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO (K843580)Graphic Controls Corp.1985-05-28
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Every clearance here is in the API, with alerts when new ones post.