Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) (K873477)Vortran Medical Technology 1, Inc.1987-10-09
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS (K873528)Intermedics, Inc.1987-10-09
MTC XI UL (K871178)Aragona Medical, Inc.1987-10-09
LOW PROFILE GASTROSTOMY (K872771)Microvasive1987-10-09
DP-700 NIKMAN DEFIB-PADS (K872793)Nikomed U.S.A., Inc.1987-10-09
STRETCHER, WHEELED, MECHANICAL (K873181)Cambridge Technologies, Inc.1987-10-09
BARD EPICARDIAL ELECTRODE ARRAY (K872231)C.R. Bard, Inc.1987-10-09
FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER (K873765)Nam Tai , Ltd.1987-10-09
LOW AIR LOSS BED (K871705)Integrated Medical Equipment Co.1987-10-09
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR (K872954)Aequitron Medical, Inc.1987-10-09
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT (K873355)Medix Biotech, Inc.1987-10-09
CHURCHILL TPN ADMINISTRATION SET (K872123)Churchill Corp.1987-10-09
MULTI-ACCESS REAGENT DISPENSER (K873416)Electro-Nucleonics Laboratories, Inc.1987-10-09
PARAGON 8500 CARDIO-PULMONARY BED (K872924)Surgi-Med, Inc.1987-10-09
DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT (K872927)C.R. Bard, Inc.1987-10-09
CONFORMA(TM) PLASTER BANDAGES (K873111)The Kendal Co.1987-10-09
PLAIN DRY GAUZE (K873523)Absorbent Cotton Co., Inc.1987-10-09
NTH 101 UL (K871177)Aragona Medical, Inc.1987-10-09
MACTRODE-II (K872784)Marquette Electronics, Inc.1987-10-09
SUTTER FINGER JOINT PROSTHESIS (K870200)Sutter Biomedical, Inc.1987-10-09
BAXA TUBING SETS (FOR PHARMACY PUMP) (K872743)Baxa Corp., Sub. of Cook Group, Inc.1987-10-09
MODEL SSR1 HOLTER MONITOR (K873337)Cardiodata Corp.1987-10-09
NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM (K872805)Squibb-Novo, Inc.1987-10-09
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS (K873193)Pharmacia, Inc.1987-10-08
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER (K871553)Hologic, Inc.1987-10-08
BAHIA ALLERGEN DISC (K873648)Incstar Corp.1987-10-08
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033 (K873482)Lakewood Biochemical Co., Inc.1987-10-08
PEDIATRIC BELLOWS (K873549)Draeger Medical, Inc.1987-10-08
MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE (K872734)Palomex Instrumentarium Corp.1987-10-08
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023 (K873480)Lakewood Biochemical Co., Inc.1987-10-08
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206 (K873479)Lakewood Biochemical Co., Inc.1987-10-08
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C) (K873827)Lakewood Biochemical Co., Inc.1987-10-08
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020 (K873483)Lakewood Biochemical Co., Inc.1987-10-08
HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016 (K873481)Lakewood Biochemical Co., Inc.1987-10-08
DIGIVIEWER (K873646)Digivision, Inc.1987-10-08
GLOBALCARE(TENS) (K873420)Oms Medico, Inc.1987-10-08
MODEL 2240 SLAVE SCOPE (K873346)Marquette Electronics, Inc.1987-10-07
SILENT GUARD CAT. NO. SG-10 (K873488)American Omni Medical, Inc.1987-10-07
PULSE-OX (K863857)Life Design Systems, Inc.1987-10-07
MODIFIED PHADEBAS RAST/PHADEZYM RAST (K872280)Pharmacia, Inc.1987-10-07
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS. (K871990)Oxford Medilog, Inc.1987-10-07
OHMEDA BIOX 3740 PULSE OXIMETER (K872772)Ohmeda Medical1987-10-07
MULTICHEM ALKALINE PHOSPHATASE (S0903) (K873761)Simmler, Inc.1987-10-07
CIBA CORNING MAGIC LITE FERRITIN (K873573)Ciba Corning Diagnostics Corp.1987-10-07
ACA URINE DRUGS OF ABUSE CONTROL (K873539)E.I. Dupont DE Nemours & Co., Inc.1987-10-07
QM300 TRANSFERRIN ANTIBODY PACK (K873789)Kallestad Diag, A Div. of Erbamont, Inc.1987-10-07
CODMAN NEUROLASE LASER SYSTEM (K872179)Codman & Shurtleff, Inc.1987-10-07
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K873668)Medix Biotech, Inc.1987-10-07
SUTURELESS TEMPORARY EPICARDIAL PACING LEAD (K873474)Symbion, Inc.1987-10-07
PULL-APART INTRODUCER (SHEATH) (K873727)Quinton, Inc.1987-10-07
RED TOP ALLERGEN DISC (K873486)Incstar Corp.1987-10-07
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT (K873676)Incstar Corp.1987-10-07
MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER (K872138)Fisher & Paykel Allied Products , Ltd.1987-10-07
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038 (K873412)Lakewood Biochemical Co., Inc.1987-10-06
EVOPORT 300 (K870567)Dantec Electronics, Inc.1987-10-06
MS-108, POWERED MUSCLE STIMULATOR (K872207)Electro Med Supply, Inc.1987-10-06
MODEL MR-45 AMBULATORY HOLTER MONITOR (K872497)Oxford Medilog, Inc.1987-10-06
VOCALTECH VOCAL FEEDBACK DEVICE (K871590)Vocaltech C/O Hogan & Hartson1987-10-06
AFFINITY HCG IMMUNIT (POLYCLONAL) (K873524)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-06
MS-112, POWERED MUSCLE STIMULATOR (K872208)Electro Med Supply, Inc.1987-10-06
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD (K873675)Medtronic Vascular1987-10-06
BNP-AMYLASE TEST (K873133)Sclavo, Inc.1987-10-06
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE (K870051)Viratek, Inc.1987-10-06
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 (K873828)Lakewood Biochemical Co., Inc.1987-10-06
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA (K872253)Surgical Laser Technologies, Inc.1987-10-06
(SPAG) MODEL SPAG-2 6000 SERIES (K871427)Viratek, Inc.1987-10-06
MD-104, POWERED MUSCLE STIMULATOR (K872206)Electro Med Supply, Inc.1987-10-06
GUS TRAC C-303 (K872780)Gus Company, Inc.1987-10-06
BIO-LOGIC BANKER (K872290)Bio-Logic Systems Corp.1987-10-06
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR (K873413)Lakewood Biochemical Co., Inc.1987-10-06
FIAX TEST KIT FOR MUMPS-G ANTIBODIES (K872733)Whittaker Bioproducts, Inc.1987-10-06
SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084 (K873411)Lakewood Biochemical Co., Inc.1987-10-06
AR DIACOAT SINGLE VISION LENSES (K873245)Seiko Optical Products of America, Inc.1987-10-05
KAWASUMI BLOOD TUBING LINE (K873516)Kawasumi Laboratories Co., Ltd.1987-10-05
CARERITE FACE MASK (K873705)Cost Rite Health Products, Inc.1987-10-05
EAR AND EYE SPONGES (K873831)Ormed Mfg., Inc.1987-10-05
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (K873435)Level 1 Technologies, Inc.1987-10-05
INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17 (K872607)Randolph Engineering, Inc.1987-10-05
FLEX GOLD (K873649)Flexmedics1987-10-05
HOSPAL DIALYSATE FOR C.A.V.H.D. (K872857)Delmed, Inc.1987-10-05
CAST CUTTER, 115V MODEL NO. 4183-106 (K873719)Martin Medical1987-10-02
ADULT WALKING HEEL PRODUCT NO. 4183-130 (K873716)Martin Medical1987-10-02
WAKO(TM) AUTOKIT UREA N (K873335)Wako Chemicals USA, Inc.1987-10-02
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD (K873538)E.I. Dupont DE Nemours & Co., Inc.1987-10-02
BINAX L.S. TSH IRMA TEST KIT (K873303)Binax, Inc.1987-10-02
PEDESTAL WALKING HEEL PRODUCT NO. 4183-133 (K873722)Martin Medical1987-10-02
CAST CUTTER, 230V MODEL NO. 4183-107 (K873720)Martin Medical1987-10-02
WAKO(TM) AUTOKIT ALP (K873333)Wako Chemicals USA, Inc.1987-10-02
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (K873324)Lakewood Biochemical Co., Inc.1987-10-02
TITAN GEL HDL CHOLESTEROL KIT (K873547)Helena Laboratories1987-10-02
MOTILITY INDOLE ORNATHINE (MIO) PRODUCT #T3053 (K873704)Lakewood Biochemical Co., Inc.1987-10-02
ANSWER OVULATION TEST KIT (K871241)Armkel, LLC1987-10-02
LYSINE IRON AGAR (LIA) PRODUCT #T3046 (K873703)Lakewood Biochemical Co., Inc.1987-10-02
ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH (K873622)E.I. Dupont DE Nemours & Co., Inc.1987-10-02
CHILD WALKING HEEL PRODUCT NO. 4183-132 (K873718)Martin Medical1987-10-02
WAKO(TM) AUTOKIT CALCIUM (K873334)Wako Chemicals USA, Inc.1987-10-02
WINK-EASE PERSONAL PROTECTIVE EYEWEAR (K873662)Eye Pro Medical Products, Inc.1987-10-02
SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080 (K873326)Lakewood Biochemical Co., Inc.1987-10-02
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL (K873037)Diagnostic Products Corp.1987-10-02
LEUCOPREP BRAND TUBE (K872775)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-10-02
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Every clearance here is in the API, with alerts when new ones post.