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
106153–106176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
K934070 · LCP
Boehringer Mannheim Corp.
Hematology · 417d
Cleared Oct 11, 1994
PEGASUS
K935009 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 356d
Cleared Oct 11, 1994
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · HSB
Howmedica Corp.
Orthopedic · 343d
Cleared Oct 11, 1994
PHILIPS TOMOSCAN SR 4000
K936272 · JAK
Philips Medical Systems North...
Radiology · 285d
Cleared Oct 11, 1994
ENDOSCOPIC PLANTAR FASCIA KIT
K940847 · HRX
Citation Medical Corp.
Orthopedic · 230d
Cleared Oct 11, 1994
COHORT BONE BRUSH
K942108 · HWE
Advanced Med/Surg, Inc.
Orthopedic · 162d
Cleared Oct 11, 1994
INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
K943253 · GCJ
Innerdyne Medical, Inc.
General & Plastic Surgery · 97d
Cleared Oct 11, 1994
TYMPANOSTOMY TUBE
K943325 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Oct 11, 1994
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
K943379 · HQC
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Oct 11, 1994
NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS
K943665 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 75d
Cleared Oct 11, 1994
VIDEO OTOSCOPE
K943731 · ERA
Cuda Products Co.
Ear, Nose, Throat · 70d
Cleared Oct 11, 1994
RYDER CONTACT LENS CASE
K943921 · LRX
Clinical Research Assoc.
Ophthalmic · 60d
Cleared Oct 11, 1994
EURO TECH DIAMOND CHIROPRACTIC TABLE
K943972 · INQ
Progressive Electrical Therapeutics
Physical Medicine · 57d
Cleared Oct 11, 1994
OXYGEN MOUTHGUARD
K944049 · MNK
Endovations, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 11, 1994
GENESIS 2000
K944206 · GEX
Ion Laser Technology
General & Plastic Surgery · 43d
Cleared Oct 11, 1994
GENESIS 2000
K944317 · GEX
Ion Laser Technology
General & Plastic Surgery · 43d
Cleared Oct 11, 1994
LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
K944640 · FBQ
Gabris Surgical Corp.
General & Plastic Surgery · 20d
Cleared Oct 11, 1994
ELECTROSURGICAL UNIT MODEL 26-0335
K944775 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 14d
Cleared Oct 07, 1994
UPPER EXTERMITY DRAPE KIT
K923960 · KKX
Medikmark, Inc.
General Hospital · 792d
Cleared Oct 07, 1994
SILICONE CATHETER REPAIR KITS
K926374 · KOC
Akcess Medical Products, Inc.
Gastroenterology & Urology · 654d
Cleared Oct 07, 1994
GUARDIAN SURGEON'S GOWNS
K931562 · FYA
Atkins Healthcare Services
General Hospital · 556d
Cleared Oct 07, 1994
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
K931752 · KWL
Corin Orthopedic Products
Orthopedic · 547d
Cleared Oct 07, 1994
CORIN THOMPSON PROSTHESIS, MODIFICATION
K931753 · KWL
Corin Orthopedic Products
Orthopedic · 547d
Cleared Oct 07, 1994
NUFFIELD TOTAL KNEE
K931960 · JWH
Turnkey Intergration USA, Inc.
Orthopedic · 534d