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
54769–54792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2008
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859 · GGN
Instrumentation Laboratory CO
Hematology · 81d
Cleared Dec 19, 2008
AMEDICA DRUG SCREEN TEST CUP
K082898 · NGL
Amedica Biotech, Inc.
Toxicology · 80d
Cleared Dec 19, 2008
SMOOTHCOOL HR SYSTEM
K082911 · GEX
Jeisys Medical, Inc.
General & Plastic Surgery · 80d
Cleared Dec 19, 2008
SURGISEAL TOPICAL SKIN ADHESIVE
K082993 · MPN
Adhezion Biomedical
General & Plastic Surgery · 73d
Cleared Dec 19, 2008
CT BRAIN PERFUSION FOR ZIOSTATION
K083084 · LLZ
Ziosoft, Inc.
Radiology · 64d
Cleared Dec 19, 2008
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K083254 · IYN
Aloka Co., Ltd.
Radiology · 45d
Cleared Dec 18, 2008
HEATER BASE, MODEL PMH7000
K080149 · BTT
Pacific Medico Co., Ltd.
Anesthesiology · 331d
Cleared Dec 18, 2008
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED,...
K080172 · MQL
Medicult A/S
Obstetrics & Gynecology · 329d
Cleared Dec 18, 2008
BIOFLEX LD-R100 TREATMENT HEAD
K081355 · ILY
Meditech International, Inc.
Physical Medicine · 218d
Cleared Dec 18, 2008
REGEN COLLAGEN SCAFFOLD (CS)
K082079 · OLC
Regen Biologics, Inc.
Orthopedic · 148d
Cleared Dec 18, 2008
VIKY
K082233 · GCJ
Endocontrol
General & Plastic Surgery · 133d
Cleared Dec 18, 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527 · HRS
Zimmer, Inc.
Orthopedic · 107d
Cleared Dec 18, 2008
GENADYNE A4 WOUND VACUUM SYSTEM
K082676 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 94d
Cleared Dec 18, 2008
URONIRS, MODEL 2000
K082701 · FEN
Urodynamix Technologies, Ltd.
Gastroenterology & Urology · 93d
Cleared Dec 18, 2008
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 92d
Cleared Dec 18, 2008
ASTOFLO PLUS
K082765 · LGZ
Stihler Electronic GmbH
General Hospital · 87d
Cleared Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
K082809 · GEX
Lumenis, Inc.
General & Plastic Surgery · 85d
Cleared Dec 18, 2008
STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
K082837 · NGT
Excelsior Medical Corp.
General Hospital · 83d
Cleared Dec 18, 2008
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 18, 2008
ALPHA ORTHOPAEDICS AT2 SYSTEM
K082956 · GEI
Alpha Orthopaedics
General & Plastic Surgery · 76d
Cleared Dec 18, 2008
WOUND FLUSH, STERILE WATER & NORMAL SALINE
K083042 · FRO
Nurse Assist, Inc.
General & Plastic Surgery · 65d
Cleared Dec 18, 2008
X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE...
K083301 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 38d
Cleared Dec 18, 2008
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
K083413 · BSZ
Philips Medical Systems
Anesthesiology · 30d
Cleared Dec 18, 2008
MODIFICATION TO T2 RECON NAIL SYSTEM
K083437 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d