Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT (K911153)Immunotech Corp.1991-06-18
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (K905383)Micro Surgical Instruments Corp.1991-06-18
LEVTECH TITANIUM BONE WIRE (K910128)Levtech, Inc.1991-06-18
MAXIBOND (K911757)Argen Precious Metals, Inc.1991-06-18
VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (K904328)Telediagnostic Systems, Inc.1991-06-18
MANUAL RESUSCITATOR (K910856)Vital Signs, Inc.1991-06-18
LIFE-02 (NON-REFILLABLE CYLINDER) (K910699)Life Corp.1991-06-18
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP (K912031)3M Avi, Inc.1991-06-18
LUER LOCK INJECTION CAP (K911931)Dmd Products1991-06-18
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS (K911236)Medtronic Vascular1991-06-18
LUNG DIFFUSION GAS MIXTURES (K911471)Norco, Inc.1991-06-18
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS (K911110)G.W.B. Intl., Ltd.1991-06-18
INFANT VENTILATOR (K911450)Preemicare Corp.1991-06-18
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (K911839)Pantex, Div. Bio-Analysis, Inc.1991-06-18
CERION HAND HELD OXYGEN ANALYZER (K911344)Ceramatec, Inc.1991-06-18
DISTENDABLE PALPATION PROBE (K912343)Dexide, Inc.1991-06-18
CERAPALL (K911670)Metalor Dental USA Corp.1991-06-18
CENTAURI YAG LASER SYST, NEUROSURGERY (K904631)Pfizer Laser Systems1991-06-18
NEXUS(TM) FEMORAL HIP STEM (K911052)Dow Corning Wright1991-06-17
QM300 CALIBRATOR G PACK (K910885)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K905754)Datex Division Instrumentarium Corp.1991-06-17
SI-1200 / ILUS (K911200)Siemens Ultrasound, Inc.1991-06-17
INTRASITE HYDROCOLLOID WOUND DRESSING (K911660)Smith & Nephew United, Inc.1991-06-17
TITAN TOTAL HIP DEVICE (K905298)Dr. Jean-Marc Guichet1991-06-17
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR (K912153)Qualitone1991-06-17
CENTAURI/PEGASUS (K905737)Pfizer Laser Systems1991-06-17
MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM (K911078)Siemens Gammasonics, Inc.1991-06-17
ARTHROSCOPY INSTRUMENT CANNULA (K911205)Davol, Inc.1991-06-17
3M LUTING CEMENT, PASTE A AND B (K911842)3M Company1991-06-17
MAGNA SURGEONS GOWNS (K911508)Dms Miami, Inc.1991-06-17
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (K910886)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
PDT CARRYALL TRANSMITTER, VARIOUS MODELS (K912379)Cardiac Pacemakers, Inc.1991-06-17
SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B (K911280)Shimadzu Medical Systems1991-06-17
MAGNA SURGICAL PACKS (K911510)Dms Miami, Inc.1991-06-17
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (K905306)Virion (U.S.), Inc.1991-06-17
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT (K911345)Diagnostic Hybrids, Inc.1991-06-17
QUALITONE MODEL 48 C-WR-BEHIND THE EAR (K912154)Qualitone1991-06-17
QM300 CONTROL G PACK (K910887)Kallestad Diag, A Div. of Erbamont, Inc.1991-06-17
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (K912112)Tomey Corporation USA1991-06-17
COULTER(R) MH010 (K911385)Coulter Electronics, Inc.1991-06-17
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL (K910434)Life Corp.1991-06-17
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK (K912321)Nova Biomedical Corp.1991-06-17
LIFE OXYGENPAC 6/12 LPM (K910435)Life Corp.1991-06-17
MAGNA OBSTETRICAL PACKS (K911509)Dms Miami, Inc.1991-06-17
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF (K911439)Canon USA, Inc.1991-06-17
B-D SAFETY-LOK(TM) I.V. NEEDLES (K911136)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-06-14
CW DOPPLER/4.5 MHZ (K903984)Diasonics, Inc.1991-06-14
LIMA COLLARED CL STEM (K910836)Lima Intl. Corp.1991-06-14
HAND CARRIED STRETCHER (K911765)L.E. Phillips Career Development Center, Inc.1991-06-14
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP (K910352)Biopro, Inc.1991-06-13
SURGICAL RUBBER GLOVES (K911268)Pacificlink Export1991-06-13
ANEMIA I, II (K911984)Ciba Corning Diagnostics Corp.1991-06-13
TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES (K905234)Percussionaire Corp.1991-06-13
RUBBER LATEX SURGEONS GLOVES (K910928)Regent Hospital Products1991-06-13
NUCLETRON PLANNING SYSTEM (K911612)Nucletron-Oldelft Corp.1991-06-13
THACKRAY TITANIUM MINI-PLATING SYSTEM (K905774)Depuy, Inc.1991-06-13
STI TISSUE MANIPULATOR (K911699)Surgical Technologies, Inc.1991-06-13
PALL 3N1 FILTER (K905794)Pall Biomedical Products Co.1991-06-13
PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA (K904573)Pentax Precision Instrument Corp.1991-06-12
ELISA COMBI-KIT HUMAN IGG SUBCLASSES (K911610)Janssen Research Foundation1991-06-12
NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION (K905810)Joint Medical Products Corp.1991-06-12
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT (K905056)Datascope Corp.1991-06-11
LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED (K905522)Laboratory Equipment Corp.1991-06-11
GESCO UMBILI-CATH (K911607)Gesco Intl., Inc.1991-06-11
LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR (K912023)Laserscope1991-06-11
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT (K910942)Mdt Biologic Co.1991-06-11
DADE(R) PROTEIN C ABNORMAL CONTRAL (K911885)Baxter Healthcare Corp1991-06-11
VZVSCAN(TM) LATEX AGGUTINATION TEST (K912239)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-06-11
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR (K910696)Valleylab, Inc.1991-06-11
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE (K911639)Vas-Cath, Inc.1991-06-11
ENDOSCOPIC CLIP APPLIER (K911817)Surgitech C/O Collier, Shannon, Rill & Scott1991-06-11
ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS (K911365)Northgate Technologies, Inc.1991-06-11
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP (K911791)Pharmacia Deltec, Inc.1991-06-11
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A (K911139)Hewlett-Packard Co.1991-06-11
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (K911104)Hgm Medical Laser Systems, Inc.1991-06-11
COLLAGEN SHIELD, VARIOUS MODELS (K905825)Chiron Ophthalmics1991-06-10
PULPDENT SEAL RITE (K911287)Pulpdent Corp.1991-06-10
LYME IGM MICROASSAY (K911330)Diamedix Corp.1991-06-10
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER (K912016)Instrumentation Laboratory CO1991-06-10
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570)Ortho Diagnostic Systems, Inc.1991-06-10
SYSTEM 50 (K905292)Folio Products, Inc.1991-06-10
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER (K905753)Hologic, Inc.1991-06-10
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH (K911367)Baxter Healthcare Corp1991-06-10
SYSTEM 70 AND 100 (K904246)Folio Products, Inc.1991-06-10
CARD GUARD, MODEL CG-2000A (K910451)Medtech Industries, Inc.1991-06-10
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571)Ortho Diagnostic Systems, Inc.1991-06-10
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES (K911091)Diagnostic Ultrasound Corp.1991-06-10
SONARSCAN 128 ULTRASOUND SCANNER (K911107)Diagnostic Sonar USA1991-06-10
LYME DISEASE MICROASSAY (K910899)Diamedix Corp.1991-06-10
OSTEOMED IB DRILL (K911937)Osteomed Corp.1991-06-10
ULTRASET CATHETER (K911294)Dhd Diemolding Healthcare Div.1991-06-10
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (K911347)Bio-Rad1991-06-10
ABUTMENT GLO (K905303)Implant Innovations International, Inc.1991-06-10
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER (K910720)C.R. Bard, Inc.1991-06-10
EIA FOR DETECTION OF ANTIBODIES H. PYLORI (K905409)E-Z-Em, Inc.1991-06-10
DEVICE PART NUMBERS: - 1400 SERIES (K911112)Minimatic Implant Technology1991-06-10
BABYLOG 8000 INFANT VENTILATOR (K903089)Drager, Inc.1991-06-10
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST (K911569)Ortho Diagnostic Systems, Inc.1991-06-10
TURBIDOMETRIC STANDARD (K911059)Scientific Device Laboratory, Inc.1991-06-10
RADIOACTIVE SEEDS (K910710)Best Assoc. Corp.1991-06-10
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Every clearance here is in the API, with alerts when new ones post.