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
153169–153192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1984
INTERDENTAL WEDGES
K840984 · DZN
Healthco, Inc.
Dental · 38d
Cleared Apr 13, 1984
BET MODEL 1010
K841000 · GZJ
Bioelectro Technologies
Neurology · 35d
Cleared Apr 13, 1984
MILLER-ABBOTT TUBE
K841033 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
DEAVER T-DRAIN & CATTEL T-DRAIN
K841034 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
ULTRA BAKER JEJUNOSTOMY TUBE
K841035 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
RECTAL BALLOON CATHETERS
K841036 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
BLAKEMORE TUBE
K841038 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
CANTOR TUBE
K841039 · KNT
Inmed Corp.
Gastroenterology & Urology · 32d
Cleared Apr 13, 1984
EMPI MODEL 984 BASIX, TENS
K841045 · GZJ
Empi
Neurology · 32d
Cleared Apr 13, 1984
BUNN 1000 OXYGEN CONCENTRATOR
K841102 · CAW
The John Bunn Co.
Anesthesiology · 31d
Cleared Apr 13, 1984
TILT TABLE 53
K841145 · INQ
S & W Enterprises, Inc.
Physical Medicine · 28d
Cleared Apr 13, 1984
VANTAGE E
K841156 · FRG
American Sterilizer Co.
General Hospital · 25d
Cleared Apr 13, 1984
LABSYSTEMS UNISKAN
K841214 · JJQ
Labsystems, Inc.
Chemistry · 22d
Cleared Apr 13, 1984
SICKLE-STAT HEMOGLOBIN S SCREEN KIT
K841272 · GHM
Clinical Technology Corp.
Hematology · 17d
Cleared Apr 13, 1984
BAG-TO-VENTILATOR SELECTOR VALVE
K841274 · BSZ
Ohio Medical Products
Anesthesiology · 17d
Cleared Apr 13, 1984
AIR-NEB NEBULIZER COMPRESSOR UNIT
K841321 · CCQ
Airmed Corp.
Anesthesiology · 11d
Cleared Apr 13, 1984
AIRCO OXYGEN REGULATOR
K841367 · CAN
Welding Products
Anesthesiology · 11d
Cleared Apr 13, 1984
WEBER-STUHMER HIP PROSTHESIS STEM
K841391 · JDI
Allo Pro Corp.
Orthopedic · 10d
Cleared Apr 13, 1984
PARAMAX TOTAL PROTEIN REAGENT TP
K845052 · CEK
American Dade
Chemistry · 58d
Cleared Apr 12, 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · DWF
Shiley, Inc.
Cardiovascular · 157d
Cleared Apr 11, 1984
ANTHRO-MODULAR TOTAL KNEE
K834432 · JWH
Zimmer, Inc.
Orthopedic · 117d
Cleared Apr 11, 1984
META-3
K841506
Whale Scientific, Inc.
Chemistry
Cleared Apr 10, 1984
NORELCO ELECTRONIC DIGITAL BP METER
K841489
North American Philips Corp.
Cardiovascular
Cleared Apr 06, 1984
CONTINUOUS VENTILATOR
K840119 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 86d