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
126649–126672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1990
URO TEX URINALS
K901000 · EYZ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Mar 26, 1990
BOUNDER VA POWER WHEELCHAIR
K901210 · ITI
21st Century Scientific, Inc.
Physical Medicine · 12d
Cleared Mar 26, 1990
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
K901240 · JDI
Med-Tek Corp.
Orthopedic · 11d
Cleared Mar 23, 1990
COLLAGEN NEUROSPONGE
K891993 · HBA
Vitaphore Corp.
Neurology · 360d
Cleared Mar 23, 1990
STP COMPLETE MODULE SET
K892425 · IYE
Leibinger & Fischer , Ltd.
Radiology · 347d
Cleared Mar 23, 1990
PLATELIA TOXO IGG KIT
K894947 · LGO
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 232d
Cleared Mar 23, 1990
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
K895792 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 176d
Cleared Mar 23, 1990
CATHETER EXTENSION SET CAT. NO. 48-3027-9
K895992 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 161d
Cleared Mar 23, 1990
TIP TOP(R) DISPENSER CAPS
K896670 · GJW
Helena Laboratories
Hematology · 116d
Cleared Mar 23, 1990
CLIP GUN WITH RANEY TYPE SCALP CLIPS
K896723 · HBO
Omni Medical Designs
Neurology · 114d
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