Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
61825–61848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 31d
Cleared Aug 31, 2006
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002
K062230 · CCW
Minrad, Inc.
Anesthesiology · 29d
Cleared Aug 31, 2006
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
K062231 · CCW
Minrad, Inc.
Anesthesiology · 29d
Cleared Aug 31, 2006
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · MQN
Synthes (Usa)
Dental · 23d
Cleared Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · JKR
Scantibodies Laboratory, Inc.
Chemistry · 177d
Cleared Aug 30, 2006
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K061353 · KWQ
Zimmer Spine, Inc.
Orthopedic · 107d
Cleared Aug 30, 2006
SPACE CPSXL BONE CEMENT
K061531 · NDN
Dfine, Inc.
Orthopedic · 89d
Cleared Aug 30, 2006
IDI-VANR ASSAY
K061686 · NIJ
Geneohm Sciences Canada, Inc.
Microbiology · 76d
Cleared Aug 29, 2006
V-808 ATOM TRANSCAPSULE
K061071 · FPL
Atom Medical, Inc.
General Hospital · 134d
Cleared Aug 29, 2006
FLEXIFIT HC432 FULL FACE MASK
K061236 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Aug 29, 2006
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
K061839 · CIG
Dade Behring, Inc.
Chemistry · 61d
Cleared Aug 28, 2006
DUPUY S-ROM STD HIP STEM PROSTHESIS
K061221 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Aug 28, 2006
QUADRATENS, MODEL QT-42
K061799 · GZJ
Bio-Research Associates, Inc.
Neurology · 63d
Cleared Aug 28, 2006
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM
K061862 · HSD
Axiom Orthopaedics, Inc.
Orthopedic · 59d
Cleared Aug 28, 2006
DISTAL RADIUS LOCKING PLATING SYSTEM
K061917 · HRS
Newclip Technics
Orthopedic · 53d
Cleared Aug 28, 2006
LC SPRINT STAR
K062158 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 31d
Cleared Aug 28, 2006
CRYOCARE CN2 SYSTEM
K062175 · GEH
Endocare, Inc.
General & Plastic Surgery · 28d
Cleared Aug 28, 2006
HALO COAGULATION CATHETER
K062225 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 26d
Cleared Aug 25, 2006
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274
K053451 · QPB
Moeller Medical GmbH & Co. KG
General & Plastic Surgery · 256d
Cleared Aug 25, 2006
N LATEX CDT
K060677 · NAO
Dade Behring, Inc.
Chemistry · 164d
Cleared Aug 25, 2006
CURATIVE DENTAL ACRYLIC TEETH
K060720 · ELM
Curative, LLC
Dental · 161d
Cleared Aug 25, 2006
TELAHEART DIGITAL RECORDER
K061293 · MWJ
North East Monitoring, Inc.
Cardiovascular · 108d
Cleared Aug 25, 2006
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
K061701 · EFA
J. Morita USA, Inc.
Dental · 70d
Cleared Aug 25, 2006
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL...
K061719 · CIG
Dade Behring, Inc.
Chemistry · 67d