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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
161593–161616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · DIF
Stanbio Laboratory
Microbiology · 25d
Cleared Dec 22, 1981
AMMONIA TEST
K813366 · JID
Wako Pure Chemical Industries, Ltd.
Chemistry · 22d
Cleared Dec 22, 1981
GRAM STAIN REAGENTS AND KIT
K813369 · JTS
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Dec 22, 1981
ELECTROLYTE GEL
K813370 · CGA
Hi Chem, Inc.
Chemistry · 22d
Cleared Dec 22, 1981
VYGON ENDOTRACHEAL TUBES
K813373 · BTR
Exco, Inc.
Anesthesiology · 21d
Cleared Dec 22, 1981
RADIOIMMUNOASSAY FOR HUMAN THYROID
K813392 · JLW
Leeco Diagnostics, Inc.
Chemistry · 19d
Cleared Dec 22, 1981
INORGANIC PHOSPHORUS REAGENT SET
K813400 · CEO
Anco Medical Reagents & Assoc.
Pathology · 18d
Cleared Dec 22, 1981
COAT-A-COUNT TESTOSTERONE RIA KIT
K813401 · CDZ
Diagnostic Products Corp.
Chemistry · 18d
Cleared Dec 22, 1981
AST(SGOT) IN VITRO DIAG. REAGENT SET
K813405 · CIT
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Dec 22, 1981
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · JHS
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Dec 22, 1981
MULTIWASH
K813426 · JQW
Flow Laboratories, Inc.
Chemistry · 15d
Cleared Dec 22, 1981
TRIGLYCERIDE CALIBRATORS
K813478 · JIS
Gilford Diagnostics
Chemistry · 21d
Cleared Dec 22, 1981
PROGESTERONE KIT BY RIA
K813484 · JLS
Immuchem Corp.
Chemistry · 21d
Cleared Dec 18, 1981
FLAT DRAIN
K813063 · GBW
Sil-Med Corp.
General & Plastic Surgery · 49d
Cleared Dec 18, 1981
CONTURA DISPOS. SURG. FACE MASK
K813078 · FXX
American Convertors Div., American...
General Hospital · 46d
Cleared Dec 18, 1981
OXYGEN CONNECTING TUBE
K813197 · BYX
Northern Medical Industries
Anesthesiology · 35d
Cleared Dec 18, 1981
BOUNDARY DRAPE TAPE
K813277 · KKX
The Buckeye Cellulose Corp.
General Hospital · 25d
Cleared Dec 18, 1981
VPI URETERAL DILATATION BALLON CATHETER
K813278 · EZN
Vance Products, Inc.
Gastroenterology & Urology · 25d
Cleared Dec 18, 1981
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · FKO
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 24d
Cleared Dec 18, 1981
DIRECT FA CONJUGATE FOR LEGIONELLA SP
K813339 · LHL
Springwood Microbiologicals
Microbiology · 24d
Cleared Dec 18, 1981
WOUND-EVAC
K813341 · GCY
Heritage Medical Products
General & Plastic Surgery · 23d
Cleared Dec 18, 1981
TOBRAMYCIN REAGENT TEST KIT
K813391 · LKB
Beckman Instruments, Inc.
Toxicology · 15d
Cleared Dec 18, 1981
MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
K813409 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 14d
Cleared Dec 18, 1981
DOCUMENT LINEARITY TEST STANDARDS
K813411 · JIX
North American Standards
Chemistry · 14d