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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93481–93504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1997
CHASE AORTIC PERFUSION CANNULA
K970914 · DWF
Chase Medical, Inc.
Cardiovascular · 62d
Cleared May 13, 1997
CHASE CORONARY OSTIAL PERFUSION CANNULA
K971041 · DWF
Chase Medical, Inc.
Cardiovascular · 53d
Cleared May 13, 1997
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
K971208 · GAM
Medline Industries, Inc.
General & Plastic Surgery · 41d
Cleared May 13, 1997
SUNGLASSES
K971412 · HQY
Team Chien Industrial Co., Ltd.
Ophthalmic · 27d
Cleared May 12, 1997
ODONT HEX SYSTEM
K961631 · DZE
Odontit S.A.
Dental · 378d
Cleared May 12, 1997
MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
K963340 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 259d
Cleared May 12, 1997
MODEL DX MICRO COMPUTER CONTROL
K970094 · ITI
Invacare Respiratory Corp.
Physical Medicine · 122d
Cleared May 12, 1997
INNOFLOUR CALIBRATOR REAGENT SET
K970509 · DLJ
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLOUR TOPIRAMATE REAGENT SET
K970510 · MSL
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLUOR TOPIRAMATE CONTROL SET
K970517 · LAS
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
MEDISYSTEMS TRANDUCER PROTECTOR
K970536 · FIB
Medisystems Corp.
Gastroenterology & Urology · 89d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared May 12, 1997
DYNAMIC WEDGE
K970564 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 88d
Cleared May 12, 1997
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
K970586 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 87d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628 · LMD
Ge Medical Systems, Inc.
Radiology · 82d
Cleared May 12, 1997
SPECTRUM DESIGNS SPECTRAGEL
K970702 · MDA
Spectrum Designs, Inc.
General & Plastic Surgery · 75d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · JKA
Greiner America, Inc.
Toxicology · 40d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971239 · JKA
Greiner America, Inc.
Chemistry · 40d
Cleared May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared May 09, 1997
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
K954577 · ILY
C.A.I. Industries Corp.
Physical Medicine · 585d
Cleared May 09, 1997
SYNTHES (U.S.A.) POLYPIN
K961608 · HTY
Synthes (Usa)
Orthopedic · 379d
Cleared May 09, 1997
TOMEY DTL ELECTRODE
K961805 · HLZ
Tomey Corporation USA
Ophthalmic · 364d
Cleared May 09, 1997
NEUROMATE STEREOTACTIC SYSTEM
K963256 · HAW
Integrated Surgical Systems, S.A.
Neurology · 263d
Cleared May 09, 1997
COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
K964239 · CCK
Spegas Industries, Ltd.
Anesthesiology · 198d