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
92521–92544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1997
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT...
K963744 · HQD
Benz Research and Development Corp.
Ophthalmic · 317d
Cleared Jul 31, 1997
TMS COMFORT SERIES NASAL CPAP MASK
K964092 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 293d
Cleared Jul 31, 1997
INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
K965001 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 227d
Cleared Jul 31, 1997
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS
K970207 · DQO
Boston Scientific Corp
Cardiovascular · 191d
Cleared Jul 31, 1997
EVT EXPANDABLE SHEATH
K970470 · DRE
Guidant Cardiac and Vascular Surgery
Cardiovascular · 174d
Cleared Jul 31, 1997
AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
K970644 · FOZ
Aeroquip Medical Products
General Hospital · 161d
Cleared Jul 31, 1997
ENDOSCOPIC VENTRICULAR CATHETER
K971617 · JXG
Integra Neurocare, LLC
Neurology · 90d
Cleared Jul 31, 1997
APOLLO KNEE FEMORAL SPACERS
K971770 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 79d
Cleared Jul 31, 1997
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC,...
K971832 · HOZ
M-Pact Worldwide Management Corp.
Ophthalmic · 73d
Cleared Jul 31, 1997
MEDIVISION ARTHROSCOP
K971996 · HRX
Medivision Scope Service Center, Inc.
Orthopedic · 62d
Cleared Jul 31, 1997
VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
K972100 · EXJ
Advanced Care Medical Products
Gastroenterology & Urology · 57d
Cleared Jul 31, 1997
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
K972153 · FNM
Decubiti Concepts, Inc.
General Hospital · 52d
Cleared Jul 31, 1997
HAND HELD MEDISPACER
K972237 · CAF
Thayer Medical Corp.
Anesthesiology · 91d
Cleared Jul 31, 1997
AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC
K972550 · ESD
Trutone
Ear, Nose, Throat · 31d
Cleared Jul 31, 1997
NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES
K972590 · HQY
Lbi U.S.A.
Ophthalmic · 20d
Cleared Jul 31, 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · KXT
Sigma Diagnostics, Inc.
Toxicology · 55d
Cleared Jul 30, 1997
INTRACAVITY NEEDLE GUIDE KIT
K955668 · ITX
Arlanda Medicinska Instrument Co. AB
Radiology · 595d
Cleared Jul 30, 1997
DUAL ROD ANTERIOR FIXATOR SYSTEM
K963780 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 313d
Cleared Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
K964282 · JMG
Boehringer Mannheim Corp.
Immunology · 275d
Cleared Jul 30, 1997
IMPLANTABLE CLIP
K970793 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Jul 30, 1997
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD
K971721 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · MBI
Arthrex, Inc.
Orthopedic · 82d
Cleared Jul 30, 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · LZO
Zimmer, Inc.
Orthopedic · 79d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
K971791 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d