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
91249–91272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1997
QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE...
K973673 · IOR
Sunrise Medical, Inc.
Physical Medicine · 55d
Cleared Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · JZG
Beckman Instruments, Inc.
Immunology · 44d
Cleared Nov 20, 1997
VENNETO
K974045 · HQY
Amsure Sports, Inc.
Ophthalmic · 27d
Cleared Nov 19, 1997
GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
K970619 · CCW
Wilson Greatbatch Technologies, Inc.
Anesthesiology · 274d
Cleared Nov 19, 1997
G.E.M. WATER SYSTEMS, INTERNATIONAL
K970674 · FIN
G.E.M. Water Systems
Gastroenterology & Urology · 268d
Cleared Nov 19, 1997
KNOTT NG TUBE
K971354 · FEG
Michael M. Knott, M.D.
Gastroenterology & Urology · 222d
Cleared Nov 19, 1997
MEDIMAGE
K972215 · LLZ
Vepro - Computersysteme GmbH
Radiology · 159d
Cleared Nov 19, 1997
BLUE MAX - 20 BALLOON DILATATION CATHETER
K972357 · LIT
Boston Scientific Corp
Cardiovascular · 147d
Cleared Nov 19, 1997
LMI IRRIGATION CATHETER (IGR)
K972623 · DXE
Lucas Medical, Inc.
Cardiovascular · 128d
Cleared Nov 19, 1997
IMATION SE-204 LASER IMAGER
K972822 · LMC
Imation Enterprises Corp.
Radiology · 112d
Cleared Nov 19, 1997
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
K973145 · JEY
Sofamor Danek USA,Inc.
Dental · 89d
Cleared Nov 19, 1997
IMTEC BONE COLLECTOR SYSTEM
K973248 · EHZ
Imtec Corp.
Dental · 82d
Cleared Nov 19, 1997
SKAR-KARE
K973271 · MDA
Target Health, Inc.
General & Plastic Surgery · 78d
Cleared Nov 19, 1997
STABILOR HN
K973288 · EJS
Degussa Corp.
Dental · 78d
Cleared Nov 19, 1997
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · KRA
Boston Scientific Corp
Cardiovascular · 56d
Cleared Nov 19, 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA...
K973861 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 41d
Cleared Nov 19, 1997
CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
K974190 · IMD
Consolidated Products & Services, Inc.
Physical Medicine · 15d
Cleared Nov 18, 1997
SAFPACE SYSTEM
K955829 · LDF
B.Braun Medical, Inc.
Cardiovascular · 693d
Cleared Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K970107 · EOQ
Urohealth Systems, Inc.
Ear, Nose, Throat · 309d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 203d
Cleared Nov 18, 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517 · KGI
Lunar Corp.
Radiology · 134d
Cleared Nov 18, 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · LYY
P.T. Latexindo Tobaperkasa
General Hospital · 133d
Cleared Nov 18, 1997
SIMPULSE
K972549 · FNM
Kinetic Concepts, Inc.
General Hospital · 133d
Cleared Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
K973085 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 92d