FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127249–127272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1990
MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K896780 · JXM
Immunotech Corp.
Toxicology · 109d
Cleared Mar 23, 1990
MICRO DAU COCAINE METABOLITE TEST KIT
K896781 · DIO
Immunotech Corp.
Toxicology · 109d
Cleared Mar 23, 1990
PHARMULATOR
K896990 · LHI
Acacia, Inc.
General Hospital · 100d
Cleared Mar 23, 1990
IMAGEMASTER-101(TM)
K897000 · LLZ
Columbia Scientific, Inc.
Radiology · 95d
Cleared Mar 23, 1990
LASER RESISTANT TRACHEAL TUBE
K897046 · CBI
Sheridan Catheter Corp.
Anesthesiology · 95d
Cleared Mar 23, 1990
NEW IOWA MOTILITY IMPLANT
K900080 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 78d
Cleared Mar 23, 1990
NEW ALLEN IMPLANT
K900081 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 78d
Cleared Mar 23, 1990
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111 · HLI
Keeler Instruments, Inc.
Ophthalmic · 73d
Cleared Mar 23, 1990
RADIO FREQUENCY RECEIVER SUBSYSTEM
K900725 · LNH
Myheal Technologies
Radiology · 36d
Cleared Mar 23, 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · JHS
Baxter Healthcare Corp
Chemistry · 30d
Cleared Mar 23, 1990
FUJI MEDICAL LASER IMAGER
K900885 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 25d
Cleared Mar 23, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K900889 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Mar 23, 1990
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · GXY
Empi
Neurology · 16d
Cleared Mar 23, 1990
MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE
K901103 · GXY
Empi
Neurology · 16d
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