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
113089–113112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1993
MARCO PROJECTION PERIMETER
K930448 · HOO
Marco Ophthalmic, Inc.
Ophthalmic · 146d
Cleared Jun 21, 1993
DENTAL LINK
K930527 · LLZ
Escan, Inc.
Radiology · 139d
Cleared Jun 21, 1993
SIM-400 SYSTEM
K931193 · KPS
Scinticor, Inc.
Radiology · 104d
Cleared Jun 21, 1993
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · LGD
Biomerieux Vitek, Inc.
Microbiology · 97d
Cleared Jun 18, 1993
SYRINGE ADAPTOR
K923966 · LHI
Excel Medical, Inc.
General Hospital · 315d
Cleared Jun 18, 1993
LAPAROSCOPIC SURGICAL INSTRUMENT
K924028 · GEI
Jana Medical
General & Plastic Surgery · 311d
Cleared Jun 18, 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · GKP
Instrumentation Laboratory CO
Hematology · 309d
Cleared Jun 18, 1993
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
K924383 · FAP
Synectics-Dantec
Gastroenterology & Urology · 297d
Cleared Jun 18, 1993
SHROUDED NEEDLE DEVICES
K924718 · FPA
Imed Corp.
General Hospital · 270d
Cleared Jun 18, 1993
MODEL 880 INFUSION PUMP, MODIFICATION
K924871 · FRN
3M Health Care, Ltd.
General Hospital · 268d
Cleared Jun 18, 1993
PHOTAC-FIL APLICAP
K925027 · EMA
Espe GmbH (Us)
Dental · 259d
Cleared Jun 18, 1993
BIO CLINIC UNDER PATIENT SCALE
K925112 · FRN
Sunrise Medical, Inc.
General Hospital · 252d
Cleared Jun 18, 1993
INTERLINK(TM) INJECTION SITE
K925126 · FPA
Baxter Healthcare Corp
General Hospital · 248d
Cleared Jun 18, 1993
BARD EPIDURAL PUMP
K925196 · FRN
C.R. Bard, Inc.
General Hospital · 246d
Cleared Jun 18, 1993
FACEBOW
K925240 · DZB
Forestadent Bernhard Forster GmbH
Dental · 245d
Cleared Jun 18, 1993
INSTRUMENT WARMER
K925530 · FMS
Superior Healthcare Group, Inc.
General Hospital · 228d
Cleared Jun 18, 1993
FST CATH UD-DUAL DUAL PRESSURE CATHETER
K926088 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 198d
Cleared Jun 18, 1993
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
K930003 · EWO
Etymotic Research
Ear, Nose, Throat · 165d
Cleared Jun 18, 1993
PALATRAY LC MINT
K930487 · EBH
Heraeus Kulzer, Inc.
Dental · 140d
Cleared Jun 18, 1993
IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
K930492 · BSZ
Premier Anesthesia Systems
Anesthesiology · 137d
Cleared Jun 18, 1993
LAERDAL ALTERNATIVE POWER, 5-6 A,5-6 B,2000
K930549 · BTA
Rustronics, Inc.
General & Plastic Surgery · 135d
Cleared Jun 18, 1993
BILATERAL TEMPORAL MANDIBULAR JOINT COIL
K930991 · LNH
Magnetic Research, Inc.
Radiology · 113d
Cleared Jun 18, 1993
MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL
K931008 · LNH
Mri Devices Corp.
Radiology · 112d
Cleared Jun 18, 1993
AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
K931151 · MLA
Microprobe Corp.
Microbiology · 102d