FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80353–80376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C...
K002417 · DJR
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C...
K002418 · DOE
Branan Medical Corporation
Toxicology · 106d
Cleared Nov 22, 2000
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST
K002587 · DJC
Branan Medical Corporation
Toxicology · 93d
Cleared Nov 22, 2000
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000...
K002598 · NHJ
J. H. Emerson Co.
Anesthesiology · 93d
Cleared Nov 22, 2000
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · FTL
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Nov 22, 2000
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM
K002683 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Nov 22, 2000
ENTERIC INJECTION CATHETER WITH IRRIGATION
K002778 · FBK
Enteric Medical Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · KOC
Transonic Systems, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 22, 2000
MODEL 6900GE-64: C-SPINE ARRAY
K002860 · MOS
Midwest Rf, LLC
Radiology · 70d
Cleared Nov 22, 2000
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE...
K003063 · KGO
Gimbel Glove Co., LLC
General Hospital · 51d
Cleared Nov 22, 2000
MICROMANIPULATOR
K003142 · MQJ
Research Instruments , Ltd.
Obstetrics & Gynecology · 43d
Cleared Nov 22, 2000
VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW
K003197 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 41d
Cleared Nov 22, 2000
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5A INJECTOR
K003302 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-5B MICROINJECTOR
K003303 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
IM-6 MICROINJECTOR
K003304 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 33d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306 · LLH
Techlab, Inc.
Microbiology · 33d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE,...
K003307 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50...
K003309 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 30d
Cleared Nov 22, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA,...
K003321 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 29d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · LZA
Medline Industries, Inc.
General Hospital · 27d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · FGE
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · KNW
Allegiance Healthcare Corp.
Gastroenterology & Urology · 23d