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
167161–167184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1980
FOLEY CATHETER
K800306 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
IRRIGATION (3-WAY) FOLEY CATHETER
K800307 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
PEDIATRIC FOLEY CATHETER
K800308 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
CONCEPT SUCTION COAGULATOR
K800321 · KNS
Concept, Inc.
Gastroenterology & Urology · 16d
Cleared Feb 28, 1980
TRI PAC MOUTH PROP
K800369 · JXL
Oxequip Health Ind.
Neurology · 8d
Cleared Feb 28, 1980
WILL CERAM LITE-CAST B
K800371 · EJH
Williams Gold Refining Co., Inc.
Dental · 8d
Cleared Feb 28, 1980
ARGYLE TRU-VOL
K800386 · BWF
Sherwood Medical Co.
Anesthesiology · 6d
Cleared Feb 26, 1980
PHARMAFLEX CRYOGENIC BAG
K792395 · KSR
Pharmachem Corp.
Hematology · 92d
Cleared Feb 26, 1980
PLS MINI
K792501 · BWJ
Staodynamics, Inc.
General Hospital · 84d
Cleared Feb 26, 1980
POINT LOCATOR STIMULATOR
K792529 · BWJ
Staodynamics, Inc.
General Hospital · 81d
Cleared Feb 26, 1980
SURGITEK URINARY DIVERSION STENT
K800109 · FAD
Medical Engineering Corp.
Gastroenterology & Urology · 41d
Cleared Feb 26, 1980
LOGO-NU-WAY
K800186 · KNX
Gary Giancarlo
Gastroenterology & Urology · 28d
Cleared Feb 26, 1980
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · FQM
Anago, Inc.
General Hospital · 27d
Cleared Feb 26, 1980
ESOPHAGEAL PILL-ELECTRODE
K800201 · DRX
Arzbaecher & Co.
Cardiovascular · 27d
Cleared Feb 26, 1980
PHARMACY ADDITIVE SYRINGE SET
K800213 · KYW
Cutter Laboratories, Inc.
General Hospital · 25d
Cleared Feb 26, 1980
SODIUM/POTASSIUM CONDITIONING REAGENT
K800216 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CHLORIDE REAGENT, CUP & CLEANER
K800217 · JFS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218 · JFL
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
SERUM CREATININE
K800219 · CGX
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · JIT
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · FJI
Travenol Laboratories, S.A.
Gastroenterology & Urology · 22d
Cleared Feb 26, 1980
ABCO EXAMINATION LAMP (GOOSENECK TYPE)
K800230 · KZF
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
K800231 · FNM
Abco Dealers, Inc.
General Hospital · 21d
Cleared Feb 26, 1980
ABCO MIDSTREAM URINE COLLECTION SET
K800233 · FMH
Abco Dealers, Inc.
General Hospital · 21d