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
126673–126696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1990
PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT
K901104 · CIT
Baxter Healthcare Corp
Chemistry · 15d
Cleared Mar 23, 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105 · CKA
Baxter Healthcare Corp
Chemistry · 15d
Cleared Mar 23, 1990
REAADS ANTI-SM TEST KIT
K901230 · LLL
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared Mar 23, 1990
RETINAL TAAK
K901275 · HQW
Alcon Surgical, Inc.
Ophthalmic · 4d
Cleared Mar 22, 1990
URO-BAGGIE
K895168 · KNX
Cwt Workshop
Gastroenterology & Urology · 212d
Cleared Mar 22, 1990
EUB-165
K895326 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 205d
Cleared Mar 22, 1990
DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
K895990 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 160d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
K895991 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 160d
Cleared Mar 22, 1990
MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE
K896205 · GCI
Dexide, Inc.
General & Plastic Surgery · 147d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
K896599 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 121d
Cleared Mar 22, 1990
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
K896600 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 121d
Cleared Mar 22, 1990
CLINICAL MERCURY THERMOMETER
K897054 · FLK
Cypress Medical Products, Ltd.
General Hospital · 94d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900008 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 79d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900012 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 79d
Cleared Mar 22, 1990
SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR
K900076 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 77d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
K900140 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
K900141 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
K900142 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 70d
Cleared Mar 22, 1990
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM
K900165 · GEX
Nidek, Inc.
General & Plastic Surgery · 69d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
K900226 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
K900242 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
K900243 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 64d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS CYCLER SET
K900323 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 58d
Cleared Mar 22, 1990
LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS
K900463 · GEX
Ximed Medical Systems
General & Plastic Surgery · 50d