Atlas FDA

1992

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

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RecordFirmDate
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA (K922736)Eastman Kodak Company1992-07-10
MRI OE 1.5 SI (K920543)Otsuka Electronics1992-07-10
PREMIER COCCIDIOIDES (K915493)Meridian Diagnostics, Inc.1992-07-10
P-LINK (K922313)Virtual Imaging1992-07-10
KODAK EKTACHEM 250 ANALYER (K922072)Eastman Kodak Company1992-07-10
ELEGANCE FT4 ELISA (K922284)Bioclone Australia Pty , Ltd.1992-07-10
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID (K922392)A-1 Hearing Aid Lab1992-07-10
OLYMPUS CALCIUM REAGENT (K922233)Olympus Corp.1992-07-10
CORTISOL CHEMILUMINESCENCE ASSAY (K922676)Nichols Institute1992-07-10
GUEDEL AIRWAY (K922748)Oem Medical Div.1992-07-10
OLYMPUS UREA NITROGEN (BUN) REAGENT (K922597)Olympus Corp.1992-07-10
MRT-150 QD KNEE COIL (K920096)Toshiba America Mri, Inc.1992-07-10
ANGEL WING SETS -- MODIFIED (K922468)Mbo Laboratories, Inc.1992-07-10
VACUTAINER BRAND LUER ADAPTER (K921520)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-10
CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION (K915791)Coritechs, Inc.1992-07-10
MP3000 SERIES III VIDEO IMAGER (K921992)International Imaging Electronics1992-07-10
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 (K922046)Bio-Rad1992-07-10
CARDIO-CARD ECG MANAGEMENT SYSTEM (K920020)Nasiff Assoc., Inc.1992-07-09
SINGLE-STEP PREGNANCY, HCG TEST (K922290)American Medical Products, Inc.1992-07-09
ZIESS ENDOPROBE (K922735)Carl Zeiss, Inc.1992-07-09
ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762)Roche Diagnostic Systems, Inc.1992-07-09
ORIEL (K920272)Truphatek, Ltd.1992-07-09
O BUTMENT HB (K921933)O Co., Inc.1992-07-08
LUMINOUS 250 FIBEROPTIC ILLUMINATOR (K921866)Progressive Dynamics, Inc.1992-07-08
SARNS 8000 MODULAR PERFUSION SYSTEM (K915183)3M Health Care, Sarns1992-07-08
CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER (K921842)Cynosure, Inc.1992-07-08
TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (K920702)Pharmacia Diagnostics, Inc.1992-07-08
ZEISS MULTI YAG LASER (K920967)Carl Zeiss, Inc.1992-07-08
MICROLINE SCREEN FOR PHENCYCLIDINE (K921651)Drug Screening Systems, Inc.1992-07-08
EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG (K922375)Excel Tech. , Ltd.1992-07-08
GRICE LAPAROSCOPIC SUTURING NEEDLE (K921922)Ideal Medical, Inc.1992-07-08
PATIENT EXAMINATION GLOVES (K921799)Consolex Corp. Sdn. Bhd.1992-07-08
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN (K915312)Puritan Bennett Corp.1992-07-08
EPISTAXIS NASAL BALLOON CATHETER (K921199)Smith & Nephew Richards, Inc.1992-07-08
HYPOTRANS MODEL 750 (K911577)Martin Mclane Medical1992-07-08
THYROXINE (T4) COATED TUBE RIA (K921935)Monobind1992-07-07
SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM (K920294)Stuart Medical, Inc.1992-07-07
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS (K921558)Medtronic Vascular1992-07-07
DADE URINE CHEMISTRY CONTROL LEVELS I AND II (K920636)Baxter Diagnostics, Inc.1992-07-07
EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200 (K920765)Electronic Monitoring Devices, Inc.1992-07-07
A-ZILICONE (K905555)Oticon Corp.1992-07-06
COULTER MH017 (K921567)Coulter Electronics, Inc.1992-07-06
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR) (K920990)Raco Products Co.1992-07-06
ECG MODULATOR (K922412)Maguire Ent., Inc.1992-07-06
DENTAL PORCELAIN (K921619)Dentsply Intl.1992-07-02
KOKO SPIROMETER (K914272)Ferraris Respiratory, Inc.1992-07-02
VITADUR ALPHA PORCELAIN (K921623)Vident1992-07-02
ELIOS DIODE OPHTHALMIC LASER (K921320)Marco Ophthalmic, Inc.1992-07-02
LEWICKY O.R.S. TUBING (K922180)O.R. Specialties, Inc.1992-07-02
MULTISPIRO-SX (K915451)Multispiro, Inc.1992-07-02
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS (K921460)Storz Instrument Co.1992-07-02
LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE (K915860)Biosound, Inc.1992-07-02
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER (K915715)Ausonics Pty , Ltd.1992-07-02
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET (K921654)Cook, Inc.1992-07-02
MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER (K921298)Cj Laser Corp.1992-07-02
OLYMPUS TRIGLYCERIDE REAGENT (K922229)Olympus Corp.1992-07-02
ELISA TUBE TSH TEST (K921958)Bio Clinic Co.1992-07-02
ALPHATEC COMPRESSION HIP SCREW SYSTEM (K921622)Alphatec Mfg., Inc.1992-07-02
MULTISPIRO-BREEZE (K913681)Multispiro, Inc.1992-07-02
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL (K921631)Cardiovascular Imaging Systems, Inc.1992-07-02
CERADELTA 2 (K921794)Metalor Dental USA Corp.1992-07-02
AGA TRACH TIES (K922657)Aga Medical Products, Inc.1992-07-02
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM (K921639)Zimmer, Inc.1992-07-02
OPERATING TABLE SYSTEM-BETAMAQUET 1140 (K920890)Stierlen-Maquet AG1992-07-02
URINARY DIVERSION EVACUATING CATHETER (K914692)Cook Urological, Inc.1992-07-02
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 (K913749)Edentec Corp.1992-07-02
MININEB (K920443)Vortran Medical Technology 1, Inc.1992-07-02
DURATECH HOSPITAL TOWEL (K920045)Techstyles1992-07-02
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 (K921707)Pentax Precision Instrument Corp.1992-07-01
MEGACART (K915225)Siemens Burdick, Inc.1992-07-01
SUNGLASSES (K920807)Libby Lee Toys, Inc.1992-07-01
UROLOGICAL BALLOON DILATATION CATHETER (K920946)Boston Scientific Corp1992-07-01
TRANSDUCER PROTECTOR (K915593)United Pharmaceutical and Medical Supply Co.1992-07-01
SDMO APPLICATOR CODE: ASN.8236 (K921961)Medi-Physics Inc. Dba Nycomed Amersham Imaging1992-07-01
THERMUFF BAG (K920153)Techstyles1992-07-01
TTL MEDICATED DRESSING (K914733)Medimix Products, Inc.1992-07-01
KODAK EKTASCAN 2180 LASER PRINTER (K921743)Eastman Kodak Company1992-07-01
OTOSONIC ACS K (K922827)Beltone Electronics Corp.1992-07-01
DIGITIZER, MODEL # 3-000A-1518 (K922619)Lorad Medical Systems, Inc.1992-07-01
AD/V SPOOLER (K921877)Adaptive Video, Inc.1992-07-01
INTEGRATED VIDEO SYSTEM (K921692)Citation Medical Corp.1992-07-01
CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM (K921563)Cardio Metrics, Inc.1992-07-01
HEALEY REVISION COMPONENT SYSTEM (K921139)Biomet, Inc.1992-07-01
BACTEC 9120 SYSTEM (K922475)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-01
SENSITITRE ARIS MODULE (K911419)Sensititre , Ltd.1992-07-01
BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. (K915786)Helix Medical, Inc.1992-06-30
INTEGRATED ENDOSCOPY SYSTEM 1000 (K920800)Biomet, Inc.1992-06-30
RX 90 ACETABULAR COMPONENT SYSTEM (K920639)Biomet, Inc.1992-06-30
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS (K921624)Intertech Resources, Inc.1992-06-30
RNA MEDICAL'S EQUIL 55 (K922357)Bionostics, Inc.1992-06-30
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE (K921607)Chiron Vision Corp.1992-06-30
FULL HEMISPHERE RING-LOC LINER (K920640)Biomet, Inc.1992-06-30
VFC UNIT (K920746)Tilane Corp.1992-06-30
NUTRIMIX MICROCOMPOUNDER (K921365)Abbott Laboratories1992-06-30
ORWO X-RAY FILM (K920539)Burkhart Roentgen Intl., Inc.1992-06-30
WIDEX MODEL D32 (K922708)Widex Hearing Aid Co., Inc.1992-06-30
#903 SILAFLEX II (K915739)Flents Products Co., Inc.1992-06-30
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER (K921661)Boehringer Mannheim Corp.1992-06-30
SD-200IEHL(TM) (K914517)Northgate Technologies, Inc.1992-06-30
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) (K921465)Helena Laboratories1992-06-29
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Every clearance here is in the API, with alerts when new ones post.