FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94873–94896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · FMF
Vascular Logics, Inc.
General Hospital · 77d
Cleared Mar 04, 1997
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
K965059 · BTA
Thomas Industries
General & Plastic Surgery · 76d
Cleared Mar 04, 1997
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
K965176 · OCZ
Pilling Weck Group
Gastroenterology & Urology · 70d
Cleared Mar 04, 1997
IMAGER TORQUE CATHETER
K965229 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Mar 04, 1997
PHASED ARRAY TRANSDUCER - - PSK-20CT
K970047 · ITX
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Mar 04, 1997
JAMES ALEX SUNGLASSES
K970101 · HQY
D&K Stores, Inc.
Ophthalmic · 50d
Cleared Mar 04, 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW...
K970105 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 50d
Cleared Mar 04, 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125 · DRX
Contour Medical Technology, Inc.
Cardiovascular · 49d
Cleared Mar 03, 1997
SYNERMED ISE REAGENTS
K962479 · CGZ
Synermed, Inc.
Chemistry · 250d
Cleared Mar 03, 1997
CANON TX-10 TONOMETER
K963079 · HKX
Canon USA, Inc.
Ophthalmic · 208d
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · LHL
Armkel, LLC
Microbiology · 192d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
K963495 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - SCREW
K963522 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
KENLOR H. PYLORI CONTROL SERUM
K964014 · LYR
Kenlor Industries, Inc.
Microbiology · 147d
Cleared Mar 03, 1997
PROCEDURE SPECIFIC KITS
K964168 · FXX
Sage Products, Inc.
General Hospital · 137d
Cleared Mar 03, 1997
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
K964698 · JKA
Andwin Scientific
General Hospital · 101d
Cleared Mar 03, 1997
RADIACARE ORAL WOUND RINSE
K964852 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 90d
Cleared Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · EBW
Bell Intl., Inc.
Dental · 89d
Cleared Mar 03, 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · FEB
Biosearch Medical Products, Inc.
General Hospital · 88d
Cleared Mar 03, 1997
MMB CALIBRATOR
K970336 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 33d
Cleared Mar 03, 1997
THYROID STIMULATING HORMONE METHOD
K970393 · JLW
Dade Chemistry Systems, Inc.
Chemistry · 28d
Cleared Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
K970527 · JJX
Abbott Laboratories
Chemistry · 20d
Cleared Feb 28, 1997
DELTA
K945117 · FLE
Pelton & Crane Co.
General Hospital · 864d
Cleared Feb 28, 1997
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · MRW
Sofamor Danek USA,Inc.
Orthopedic · 609d