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
126913–126936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1990
BULB IRRIGATION TRAY
K900736 · EYN
Orion Life Systems, Inc.
General & Plastic Surgery · 60d
Cleared Apr 16, 1990
SIEMENS STEREODYNATOR 828
K881431 · IPF
Elmed, Inc.
Physical Medicine · 741d
Cleared Apr 16, 1990
PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY)
K894090 · LYY
Everbest Machinery (U.S.A.) Co. , Ltd.
General Hospital · 311d
Cleared Apr 16, 1990
EVOLUTION ULTRASONIC
K894215 · CCQ
Medical Industries America, Inc.
Anesthesiology · 301d
Cleared Apr 16, 1990
GLASION
K895386 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 229d
Cleared Apr 16, 1990
AHAC ITE MODEL ENTENDRE
K895843 · ESD
Aroostook Hearing Aid
Ear, Nose, Throat · 195d
Cleared Apr 16, 1990
URINARY LEG BAG
K896129 · FAQ
Cypress Medical Products, Ltd.
Gastroenterology & Urology · 175d
Cleared Apr 16, 1990
SR-IVOCAP
K896130 · EBI
Ivoclar North America, Inc.
Dental · 175d
Cleared Apr 16, 1990
SR-IVOSEAL
K896139 · EBI
Ivoclar North America, Inc.
Dental · 175d
Cleared Apr 16, 1990
BIOPSY FORCEP (NON-ELECTRIC)
K896147 · FCL
Portlyn Corp.
Gastroenterology & Urology · 175d
Cleared Apr 16, 1990
RHINOMANOMETER
K896263 · BXQ
Jedmed Instrument Co.
Anesthesiology · 167d
Cleared Apr 16, 1990
TITAMED ANTWERP SYSTEM
K896404 · JEY
Optik
Dental · 160d
Cleared Apr 16, 1990
PPG BIOMEDICAL VENTILATOR MODEL IRISA
K896442 · CBK
Ppg Industries, Inc.
Anesthesiology · 158d
Cleared Apr 16, 1990
ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
K896492 · LQF
Gen-Probe, Inc.
Microbiology · 154d
Cleared Apr 16, 1990
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K896684 · JQW
Schiff & Co.
Chemistry · 139d
Cleared Apr 16, 1990
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · GAA
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 119d
Cleared Apr 16, 1990
MODIFIED PGL ABSORBABLE STAPLE*
K900069 · GDG
United States Surgical, A Division of...
General & Plastic Surgery · 102d
Cleared Apr 16, 1990
CL-OPE CONTACT LASER SYSTEM
K900128 · GEX
Lca, Inc.
General & Plastic Surgery · 97d
Cleared Apr 16, 1990
EXACT ONE(TM) HEMATOLOGY ANALYZER
K900276 · GKZ
Exact Science, Inc.
Hematology · 87d
Cleared Apr 16, 1990
MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES
K900316 · HDR
Irvine Scientific
Obstetrics & Gynecology · 83d
Cleared Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K900333 · LKD
Radiometer America, Inc.
Anesthesiology · 83d
Cleared Apr 16, 1990
TOXO IGG ELISA TEST
K900354 · LGD
Gull Laboratories, Inc.
Microbiology · 81d
Cleared Apr 16, 1990
ONE/CIRC (CIRCUMCISION CLAMP)
K900370 · HFX
Bionix Development Corp.
Obstetrics & Gynecology · 81d
Cleared Apr 16, 1990
OPAQUE PORCELAIN
K900393 · EIH
Dentsply Intl.
Dental · 77d