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
93169–93192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1997
OLYMPUS CK-MB REAGENT
K971817 · JLB
Olympus America, Inc.
Chemistry · 26d
Cleared Jun 11, 1997
ACCUTEST HCG-URINE
K971886 · JHI
Unotech Diagnostics, Inc.
Chemistry · 20d
Cleared Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954 · JJY
Bio-Rad
Chemistry · 14d
Cleared Jun 10, 1997
HOTMAN
K952172 · DSB
Hemo Sapiens, Inc.
Cardiovascular · 764d
Cleared Jun 10, 1997
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
K963717 · BSN
Millipore Corp.
Anesthesiology · 267d
Cleared Jun 10, 1997
WHITE RIVER AUTOMATIC BREAST PUMP
K964679 · HGX
White River Concepts
Obstetrics & Gynecology · 201d
Cleared Jun 10, 1997
CLYDE CORONARY GUIDEWIRE
K970528 · DQX
Schneider (Europe) GmbH
Cardiovascular · 119d
Cleared Jun 10, 1997
SOLOS 10MM OPERATING LAPAROSCOPE
K970917 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 90d
Cleared Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · LJH
Medline Industries, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 10, 1997
O.B. APPLICATOR TAMPONS
K970954 · HEB
Personal Products Co.
Obstetrics & Gynecology · 85d
Cleared Jun 10, 1997
SCAR HEAL
K971468 · MDA
Specialty Systems, Inc.
General & Plastic Surgery · 49d
Cleared Jun 10, 1997
BREATH TAKER
K971887 · LCN
Hofa, LLC
Dental · 20d
Cleared Jun 09, 1997
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005 · MPA
Synergetics, Inc.
Ophthalmic · 275d
Cleared Jun 09, 1997
BIO-ANCHOR
K964805 · MAI
Linvatec Corp.
Orthopedic · 192d
Cleared Jun 09, 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · MAI
Ethicon, Inc.
Orthopedic · 90d
Cleared Jun 09, 1997
DEPUY LOW PROFILE BONE SCREW
K970929 · HWC
Depuy, Inc.
Orthopedic · 88d
Cleared Jun 09, 1997
OPPORTUNITY INC. GENERAL PURPOSE TRAY
K971062 · LRO
Opportunity, Inc.
General & Plastic Surgery · 77d
Cleared Jun 09, 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · HQC
Visioncare Devices, Inc.
Ophthalmic · 77d
Cleared Jun 06, 1997
STERRADD STERILIZATION SYSTEM
K954142 · FLE
Advanced Sterilization Products
General Hospital · 644d
Cleared Jun 06, 1997
BIO-PLEXUS DROP-IT NEEDLE HOLDER
K963748 · FMI
Bio-Plexus, Inc.
General Hospital · 262d
Cleared Jun 06, 1997
EXTRESAFE PHLEBOTOMY
K964042 · FMI
Specialized Health Products, Inc.
General Hospital · 241d
Cleared Jun 06, 1997
DOUBLE UP BREAST PUMP
K964396 · HGX
The Natural Choice Co., Inc.
Obstetrics & Gynecology · 214d
Cleared Jun 06, 1997
ANOKRYO
K964634 · FFP
Mk Conquest Intl., Inc.
Gastroenterology & Urology · 199d
Cleared Jun 06, 1997
GSI SA60 DPOAE SYSTEM
K970324 · ETW
Grason-Stadler, Inc.
Ear, Nose, Throat · 130d