Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WECK TROCAR (K915378)Edward Weck, Inc.1992-06-29
BIVONA-COLORADO VOICE PROSTHESIS (K915761)Bivona Medical Technologies1992-06-29
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER (K915351)Medtronics Interventional Vascular1992-06-29
COXSACKIE VIRUS B1-B6 CF ANTIGENS (K921618)Virion (U.S.), Inc.1992-06-29
POWERED VACUUM ASPIRATOR 1110-G-030 (K920287)Stirn Industries1992-06-29
MOVIT DEVICE (K921710)John J. Navar, M.D.1992-06-29
GEL-TAC (K915328)Katecho, Inc.1992-06-29
POWERED VACUUM ASPIRATOR 1110-G-062 (K920288)Stirn Industries1992-06-29
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (K921700)Medix Biotech, Inc.1992-06-29
IVOS ANALYZER (K920719)Hamilton Thorne Research1992-06-29
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (K921556)Medical Diagnostic Technologies, Inc.1992-06-29
NEEDLECRIC (K914471)Ajs Medical Co., Inc.1992-06-29
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED (K914945)Bruel & Kjaer Industri A/S1992-06-26
EAGLE 3000 SDS (K912471)Amsco Co.1992-06-26
QBC FIBRINOGEN (K920258)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-06-26
RNA MEDICAL TONOMETER (K922386)Bionostics, Inc.1992-06-26
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM (K921480)Acu-Med, Inc.1992-06-26
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER (K922220)Olympus Corp.1992-06-25
LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER (K921380)Laserscope1992-06-25
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER (K920789)Fonar Corp.1992-06-25
ACUSON IMAGE MANAGEMENT SYSTEM (K921670)Acuson Corp.1992-06-25
PCA ACETABULAR INSERT II (K921384)Howmedica Corp.1992-06-25
MILENIA FOLIC ACID (K921614)Diagnostic Products Corp.1992-06-25
MKS BEAM OUTLINE PROJECTOR (K921876)Medical Knowledge Systems, Inc.1992-06-25
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS (K913367)Fisher & Paykel Electronics , Ltd.1992-06-25
OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH (K921469)Ceramed Corp.1992-06-25
PRECISION STRATA TOTAL HIP STEM (K921383)Howmedica Corp.1992-06-25
OLYMPUS GGT REAGENT (K922230)Olympus Corp.1992-06-25
SLEEPTRACE 2000 (K911874)Areca Science Corp.1992-06-25
SUNGLASSES AND EYEGLASS FRAMES (K920764)New Optic Srl1992-06-25
BARRIER INTEGRITY MONITOR (K915662)Incomed, Inc.1992-06-25
MAESTRO DIGITAL VIDEO SYSTEM (K920373)International Imaging Electronics1992-06-24
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED (K915890)Pegasus Research Corp.1992-06-24
AUTOMATIC TUBING CLAMP (K914459)Rocky Mountain Research, Inc.1992-06-24
STATVIEW (K921527)Image Data Corp.1992-06-24
P-300 CAPNOGRAPH AND PULSE OXIMETER (K915773)Pryon Corp.1992-06-24
EXCEL DUOPAULSE MODEL 2000 (K915679)Excel Tech. , Ltd.1992-06-24
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE (K922612)Cholestech Corp.1992-06-24
THYROXINE (FPIA) KIT (K921904)Tudor Laboratories, Inc.1992-06-24
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT (K915735)Abbott Laboratories1992-06-24
BACTON(TM), AUTO-APO A-1 REAGENT (K921795)Bacton Assay Systems, Inc.1992-06-23
TYPE 9050/NEO (K912183)S & W Medico Teknik1992-06-23
NEOPLASTINE CI PLUS (K922040)American Bioproducts Co.1992-06-23
LEVY ARTICULATING RETRACTOR (K920471)Lifeguard Medical Products, Inc.1992-06-23
DISPOSABLE LATEX EXAMINATION GLOVES (K921438)Perlink USA, Inc.1992-06-23
MODIFIED SITE POWER HANDPIECE (K922077)Chiron Vision Corp.1992-06-23
BREATH-EASY, MODIFICATION (K914416)Icor AB1992-06-23
MG-1001 TUBE HOUSING ASSEMBLY (K921316)Magma Corp.1992-06-22
VITA IN-CERAM (K913644)Vident1992-06-22
MODIFIED ORTHO EBV VCA-IGG ELISA (K920412)Ortho Diagnostic Systems, Inc.1992-06-22
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN (K921479)Degussa AG1992-06-22
BACTON(TM), AUTO-APO B REAGENT (K921862)Bacton Assay Systems, Inc.1992-06-22
DISPOSABLE O.R. TOWEL, STERILE (K915740)American Threshold Industries, Inc.1992-06-22
COILS FOR RX4000 & RX5000 MRI SYSTEMS (K920254)Resonex, Inc.1992-06-22
IMZ SURGICAL INSTRUMENT TRAY (K921246)Interpore Intl.1992-06-22
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT (K913324)Neward Enterprises, Inc.1992-06-22
JOBST EXTREMITY PUMP SYSTEM 7500 (K921562)Jobst Institute, Inc.1992-06-22
MULTI JOINT WEIGHT SYSTEM MODEL #940-100 (K922606)Biodan Medical Systems, Ltd.1992-06-19
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS (K922160)Aquamotion, Inc.1992-06-19
CD8 MONOCLONAL ANTIBODIES (K914847)Gen Trak, Inc.1992-06-19
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM (K922712)Ambu, Inc.1992-06-19
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 (K922602)Biodan Medical Systems, Ltd.1992-06-19
SPUR ADULT WITH OPEN RESERVOIR SYSTEM (K922707)Ambu, Inc.1992-06-19
TSRH(TM) LATERAL OFFSET PLATE (K914306)Sofamor Danek Mfg., Inc.1992-06-19
AMERICA SYSTEM (K920608)I. Klimov Co.1992-06-19
CD4 MONOCLONAL ANTIBODIES (K914848)Gen Trak, Inc.1992-06-19
BACTIDROP INDOLE (ERLICH'S) (K920973)Remel Co.1992-06-19
TOTAL WORK INTEGRATOR, MODEL #940-110 (K922603)Biodan Medical Systems, Ltd.1992-06-19
ULTRA-CORE BIOPSY NEEDLES (K921418)Medical Device Technologies, Inc.1992-06-19
KERATOREF L60 (K922253)Luneau Ophtalmologie SA1992-06-19
URINE CULTUR STABILIZATION TRANSPORT TUBE (K920761)Bio Medicus, Inc.1992-06-19
BACTIDROP ACRIDINE ORANGE (K920974)Remel Co.1992-06-19
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT (K921183)Shield Diagnostics, Ltd.1992-06-19
ROADRUNNER ELECTRIC SCOOTER-3 WHEELED (K922304)Mobility Mfg. Co.1992-06-19
COYOTE ELECTRIC SCOOTER-3WHEELED (K922305)Mobility Mfg. Co.1992-06-19
GREAT TOE IMPLANT (K920667)Acu Med, Inc.1992-06-19
CD2 MONOCLONAL ANTIBODIES (K914846)Gen Trak, Inc.1992-06-19
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION (K922010)Alexon, Inc.1992-06-19
DRYSLIDE(TM), PYR (K921583)Difco Laboratories, Inc.1992-06-19
COBAS CORE FERRITIN EIA (K920829)Roche Diagnostic Systems, Inc.1992-06-19
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 (K920927)Helena Laboratories1992-06-19
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR (K915694)Medical Devices, Inc.1992-06-18
BAIR HUGGER CUB BLANKET- SHORT MODEL 536 (K920432)Augustine Medical, Inc.1992-06-18
ARROW QUADPOLAR MAPPING/PACING CATHETER (K911065)Arrow Intl., Inc.1992-06-18
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY (K921816)Biomerieux Vitek, Inc.1992-06-18
SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE (K921671)Surgical Products Corp.1992-06-18
VITA OMEGA PORCELAIN (K921474)Vident1992-06-18
ULTRALINE STERILE DISPOSABLE FIBER (K921807)Heraeus Lasersonics, Inc.1992-06-18
ULTRA PVD (K912925)Advanced Medical Products, Inc.1992-06-18
ACUSON C366 TRANSDUCER (K911916)Acuson Corp.1992-06-18
VJW2919 PNEUMATIC COMPRESSION UPGRADE (K920938)Varian Canada, Inc.1992-06-17
HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES (K915086)Hpi, Inc.1992-06-17
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL (K921943)Schneider Intl., Ltd.1992-06-17
DERMAGRAN WET DRESSING (K914746)Derma Sciences, Inc.1992-06-17
ENTENDED LINE ACCESSORIES & CONNECTORS (K921512)Intersurgical, Inc.1992-06-17
CATHETER MOUNTS -- MODIFICATION (K921511)Intersurgical, Inc.1992-06-17
VERIMED PERINEOMETER (K913912)Verimed Holdings, Inc.1992-06-16
POLARIS, GYNECOLOGY INDICATIONS (K912067)Pfizer Laser Systems1992-06-16
SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES (K922012)Shimadzu Medical Systems1992-06-16
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE (K921147)Cardiovascular Imaging Systems, Inc.1992-06-16
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Every clearance here is in the API, with alerts when new ones post.