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
166657–166680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1980
GENERAL UTILITY SURG. SCISSORS #460180-
K800721 · HRR
Edward Weck, Inc.
Orthopedic · 37d
Cleared May 08, 1980
EYEWI ANKORS
K800726 · KMK
Eyevi & Co.
General Hospital · 37d
Cleared May 08, 1980
RAPID FERMENTATION AGAR (RFA)
K800734 · JSE
Remel Co.
Microbiology · 36d
Cleared May 08, 1980
STOMAHESIVE STERILE WAFER
K800750 · EXB
Squibb & Sons, Inc.
Gastroenterology & Urology · 34d
Cleared May 08, 1980
RADX VENT-AL MECHANICAL RESPORATOR
K800751 · KPX
Radx Corp.
Radiology · 34d
Cleared May 08, 1980
BOEHRINGER LABS AMBULATORY PEEP VALVE
K800755 · BYE
Boehringer Laboratories
Anesthesiology · 34d
Cleared May 08, 1980
INJECTION SITE, CODE NO. 3100
K800786 · FOZ
Quest Medical, Inc.
General Hospital · 30d
Cleared May 08, 1980
MYERSON R&KENSON R PORCELAIN ANT&POS.-
K800829 · ELL
Myerson Tooth Corp.
Dental · 24d
Cleared May 08, 1980
PY-CO-PROX TM DENTAL BRUSH
K800831 · EFW
Block Drug Company, Inc.
Dental · 24d
Cleared May 08, 1980
ENTELLAN
K800847 · KEP
Mcb Manufacturing Chemists, Inc.
Hematology · 23d
Cleared May 08, 1980
TMS 1000 TEMP. MONITOR & PROBES
K800849 · FLL
Gics Pharmaceuticals
General Hospital · 23d
Cleared May 08, 1980
TIME STEAM AUTOCLAVE TAPE
K800873 · JOJ
Professional Tape Co., Inc.
General Hospital · 21d
Cleared May 08, 1980
PELVIC EXAM TRAY
K800874 · HHD
Pharmaseal Laboratories
Obstetrics & Gynecology · 21d
Cleared May 08, 1980
DISPOSABLE BERMAN AIRWAYS
K800881 · CAE
Harvard Laboratories
Anesthesiology · 21d
Cleared May 08, 1980
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · DEW
Icl Scientific
Immunology · 20d
Cleared May 08, 1980
SIEMENS-ELEMA AB O2-AIR MIXER 960
K800905 · BZR
Siemens Elema AB
Anesthesiology · 17d
Cleared May 08, 1980
NO-BOIL FOLATE KIT #RP-500
K800914 · CGN
Ria Products, Inc.
Chemistry · 17d
Cleared May 08, 1980
P1 BLOOD GROUP SUBSTANCE
K800916 · KSX
Travenol Laboratories, S.A.
Hematology · 16d
Cleared May 08, 1980
ORAVIEW BY WATER PIK
K800919 · EAX
Teledyne, Inc.
Dental · 17d
Cleared May 08, 1980
THROMBOQUIK THROMBIN REAGENT PROD. #3551
K800926 · GJA
General Diagnostics
Hematology · 17d
Cleared May 08, 1980
TRI-CHECK
K800938 · JPK
Scientific Standards, Inc.
Hematology · 16d
Cleared May 08, 1980
VOLU-SOL EOSIN Y STAIN
K800942 · HYB
Volu Sol Medical Industries
Hematology · 16d
Cleared May 08, 1980
PENTEX BOVINE ALBUMIN 30% SOLUTION
K800943 · KSG
Miles Laboratories, Inc.
Hematology · 16d
Cleared May 08, 1980
RADIOEAR MODEL REI HEARING AID
K800945 · ESD
Radioear Corp.
Ear, Nose, Throat · 16d