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

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176,076 results
68857–68880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2004
ALOCLAIR ORAL GEL
K040950 · OLR
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 70d
Cleared Jun 21, 2004
STARPACS ORTHOPEDICS SYSTEM
K041500 · LLZ
Infinitt Co., Ltd.
Radiology · 14d
Cleared Jun 18, 2004
M3 MICROKERATOME
K032836 · HNO
Moria SA
Ophthalmic · 281d
Cleared Jun 18, 2004
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
K033785 · EJR
Discus Dental, Inc.
Dental · 197d
Cleared Jun 18, 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · DCK
Cholestech Corp.
Chemistry · 106d
Cleared Jun 18, 2004
MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX...
K040704 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 92d
Cleared Jun 18, 2004
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
K040728 · DYB
AngioDynamics, Inc.
Cardiovascular · 88d
Cleared Jun 18, 2004
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · DXC
Vascular Solutions, Inc.
Cardiovascular · 88d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 18, 2004
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K040830 · DQO
NuMED, Inc.
Cardiovascular · 79d
Cleared Jun 18, 2004
RED, WHITE & BLUE
K040874 · NXC
Allesee Orthodontic Appliances
Dental · 77d
Cleared Jun 18, 2004
CRYOCHECK CLOT C
K040987 · GGP
Precision Biologic, Inc.
Hematology · 64d
Cleared Jun 18, 2004
TAIDOC CHECK
K041107 · NBW
Taidoc Technology Corporation
Chemistry · 51d
Cleared Jun 18, 2004
LED TURBO-PEN
K041303 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 32d
Cleared Jun 18, 2004
STABIL-O-GRAPH
K041313 · DXN
I.E.M. GmbH
Cardiovascular · 32d
Cleared Jun 18, 2004
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
K041412 · CBK
Respironics California, Inc.
Anesthesiology · 22d
Cleared Jun 18, 2004
MODIFICATION TO NICO WITH MARS, MODEL 7300
K041450 · CCK
Respironics Novametrix, Inc.
Anesthesiology · 17d
Cleared Jun 17, 2004
THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
K023956 · FLL
Mesure Technology Co., Ltd.
General Hospital · 568d
Cleared Jun 17, 2004
BBP BONE SUBSTITUTES
K030195 · LYC
Oct, USA, Inc.
Dental · 513d
Cleared Jun 17, 2004
NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
K040310 · LLZ
National Display Systems
Radiology · 129d
Cleared Jun 17, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 101d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · KWQ
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jun 17, 2004
ALADYN RIGID SPINE PLATE
K040747 · MNH
Scient'X
Orthopedic · 86d
Cleared Jun 17, 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749 · KRO
Howmedica Osteonics Corp.
Orthopedic · 86d