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
66049–66072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2005
LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE
K050612 · EKX
Lightspeed Technology, Inc.
Dental · 55d
Cleared May 04, 2005
CARDIOVIT AT-10PLUS
K050686 · DPS
Schiller AG
Cardiovascular · 49d
Cleared May 04, 2005
ABC 2 SCREW
K050813 · KWQ
Aesculap, Inc.
Orthopedic · 34d
Cleared May 04, 2005
THE LF-P CERAMIC SYSTEM
K050838 · EIH
Jensen Industries, Inc.
Dental · 33d
Cleared May 04, 2005
HA COATED LAG SCREW
K050849 · KTT
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 04, 2005
PMP4 SPIROPRO
K050853 · BZH
Card Guard Scientific Survival , Ltd.
Anesthesiology · 30d
Cleared May 04, 2005
KNEE FUSION NAIL
K050938 · JDS
Smith & Nephew, Inc.
Orthopedic · 20d
Cleared May 03, 2005
MICROCYN WOUND CARE DRESSING
K041161 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 365d
Cleared May 03, 2005
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
K041184 · LRK
Nti-Tss, Inc.
Dental · 362d
Cleared May 03, 2005
MODIFICATION TO MBCP
K043005 · MQV
Biomatlante
Orthopedic · 183d
Cleared May 03, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050605 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 54d
Cleared May 03, 2005
E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
K051077 · EGS
Aseptico, Inc.
Dental · 6d
Cleared May 02, 2005
PREMERE DELIVERY SHEATH, MODEL PDS
K043084 · DYB
Velocimed, Inc.
Cardiovascular · 175d
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495 · FMF
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared May 02, 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S,...
K050521 · MQF
Inntec, Inc.
Obstetrics & Gynecology · 62d
Cleared May 02, 2005
AMSINO I.V. START KIT
K050654 · LRS
Amsino International, Inc.
General & Plastic Surgery · 49d
Cleared May 02, 2005
AMSINO SUTURE REMOVAL KIT
K050656 · MCZ
Amsino International, Inc.
General & Plastic Surgery · 49d
Cleared May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · GJT
Instrumentation Laboratory CO
Hematology · 48d
Cleared May 02, 2005
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · CZW
Dade Behring, Inc.
Immunology · 48d
Cleared May 02, 2005
ERCHONIA EVRL LASER
K050672 · GEX
Erchonia Medical, Inc.
General & Plastic Surgery · 48d
Cleared May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
K050872 · LFR
Roche Diagnostics Corp.
Chemistry · 26d
Cleared May 02, 2005
REMREST HEATED HUMIDIFIER
K050990 · BTT
Medical Industries America, Inc.
Anesthesiology · 13d
Cleared May 02, 2005
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
K051010 · EJJ
Septodont
Dental · 11d
Cleared Apr 29, 2005
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120 · LLM
DiaSorin, Inc.
Microbiology · 465d