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
105601–105624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1994
CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR
K942413 · GWG
Clarus Medical Systems, Inc.
Neurology · 186d
Cleared Nov 22, 1994
SYNERGY II
K942445 · MMZ
Synectics Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Nov 22, 1994
GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS
K942544 · LQC
Medi-Globe Corp.
Gastroenterology & Urology · 175d
Cleared Nov 22, 1994
BILIRUBIN (DIRECT) QVET
K942949 · CIG
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
TRIGLYCERODES QVET
K942998 · CDT
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
CREATININE QVET
K943005 · CGX
Prisma Systems
Chemistry · 152d
Cleared Nov 22, 1994
AD/V IMAGEPLEX(TM)
K943158 · LMD
Adaptive Video, Inc.
Radiology · 144d
Cleared Nov 22, 1994
SCIMED CHOICE(TM) PTCA GUIDE WIRE
K943192 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 140d
Cleared Nov 22, 1994
CEMAX SCANLINK V
K943357 · LMA
Cemax, Inc.
Radiology · 133d
Cleared Nov 22, 1994
IMAGING WORKBENCH
K943383 · LMD
Brit Systems, Inc.
Radiology · 132d
Cleared Nov 22, 1994
ARTHROSCOPE
K943628 · HRX
Electro Fiberoptics Corp.
Orthopedic · 119d
Cleared Nov 22, 1994
HEARING AID (ACCESSORY)
K944009 · ESD
Phoenix Management, Inc.
Ear, Nose, Throat · 98d
Cleared Nov 22, 1994
SURGICAL INSTRUMENT TRAY
K944025 · FSM
Riley Medical, Inc.
General & Plastic Surgery · 97d
Cleared Nov 22, 1994
ALT QVET
K944080 · CKA
Prisma Systems
Chemistry · 92d
Cleared Nov 22, 1994
OKTAS INTRA-ORAL DENTAL CAMERA
K944256 · EIA
Oktas
Dental · 83d
Cleared Nov 22, 1994
KARL STORZ INSULATED SCISSORS
K944298 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 22, 1994
SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR
K944312 · HQY
Shelin International Ent., Inc.
Ophthalmic · 81d
Cleared Nov 22, 1994
BLOCKING TRAY
K944315 · IYE
Medtec, Inc.
Radiology · 85d
Cleared Nov 22, 1994
FOCOMETER
K944402 · HLJ
Lacrimedics, Inc.
Ophthalmic · 71d
Cleared Nov 22, 1994
QUANTITATE URIC ACID VERIFIER SET
K944453 · JJX
Beckman Instruments, Inc.
Chemistry · 71d
Cleared Nov 22, 1994
DERMAGRAN HYDROPHILIC OINTMENT
K944491 · KMF
Derma Sciences, Inc.
General & Plastic Surgery · 70d
Cleared Nov 22, 1994
KERATRON CORNEAL TOPOGRAPHER
K944616 · HLQ
Alliance Medical Marketinig
Ophthalmic · 63d
Cleared Nov 22, 1994
WANG BRONCHIAL NEEDLE BRUSH
K944650 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 62d
Cleared Nov 22, 1994
ECG ELECTRODE
K944655 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 62d