FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135937–135960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1988
LABELING CHANGE TO SURGICAL FACE MASK
K881910 · FXX
Louis M. Gerson Co., Inc.
General Hospital · 19d
Cleared May 17, 1988
PREGNANCY (HCG) CARD & LIQUID TEST
K880163 · JHJ
Ampcor, Inc.
Chemistry · 125d
Cleared May 17, 1988
MAGNESIUM LIQUID STABLE REAGENT SET
K881300 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 50d
Cleared May 17, 1988
BREATH-EASY
K881308 · BYD
Icor AB
Anesthesiology · 50d
Cleared May 17, 1988
SIMPLICITY SERIES 5
K881634 · IQA
Quartet Technology, Inc.
Physical Medicine · 33d
Cleared May 17, 1988
BATTERY PACKS FOR CARDIOVASCULAR UNITS
K881643 · MHX
Dowit Service Co., Inc.
Cardiovascular · 43d
Cleared May 17, 1988
REM 250 THREE WHEELED ELECTRIC CART
K881766 · INI
Royal Enterprises Manufacturing, Inc.
Physical Medicine · 22d
Cleared May 16, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K875118 · JOM
Bloodflow Laboratory, Inc.
Cardiovascular · 153d
Cleared May 16, 1988
BRUSHRITE
K880442 · JEG
Pro Care Laboratories, Inc.
Anesthesiology · 104d
Cleared May 16, 1988
ADVANCE* AND DAISY* PREGNANCY TEST
K880472 · LCX
Advanced Care Products
Chemistry · 102d
Cleared May 16, 1988
FUJI CAP II CAPSULE & APPLIER
K880848 · EMA
G-C Intl. Corp.
Dental · 76d
Cleared May 16, 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · DHB
Pharmacia, Inc.
Immunology · 75d
Cleared May 16, 1988
VASCU-CARE ANGIOSCOPE
K880927 · DQX
Vascu-Care, Inc.
Cardiovascular · 73d
Cleared May 16, 1988
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
K881197 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 56d
Cleared May 16, 1988
HR VACUTRAC
K881201 · JKA
Icu Medical, Inc.
Chemistry · 56d
Cleared May 16, 1988
PROBE SHEATH FOR ADMS ULTRASOUND PROBE
K881208 · IYO
Advanced Diagnostic Medical Systems,...
Radiology · 56d
Cleared May 16, 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · JGS
Nova Biomedical Corp.
Chemistry · 54d
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267 · JHX
Biotrol, USA, Inc.
Chemistry · 53d
Cleared May 16, 1988
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
K881275 · JJY
Fisher Scientific Co., LLC
Chemistry · 52d
Cleared May 16, 1988
CONDOM-MATE VAGINAL LUBRICANT
K881338 · KMJ
Upsher-Smith Laboratories, Inc.
General Hospital · 48d
Cleared May 16, 1988
BIOTROL BUN ENZYMATIQUE UV H.P.
K881366 · CDQ
Biotrol, USA, Inc.
Chemistry · 46d
Cleared May 16, 1988
WESBLOT RNP-SM TEST
K881379 · LKP
American Bionetics, Inc.
Immunology · 45d
Cleared May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · LJN
Ortho Diagnostic Systems, Inc.
Microbiology · 319d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Abbott Laboratories
Microbiology · 296d