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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
49681–49704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2010
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE...
K100912 · GXZ
Kirwan Surgical Products, Inc.
Neurology · 140d
Cleared Aug 19, 2010
GRANDIO FLOW
K101213 · EBF
Voco GmbH
Dental · 111d
Cleared Aug 19, 2010
SYNERGY CT PICC
K101329 · LJS
Health Line International Corporation
General Hospital · 99d
Cleared Aug 19, 2010
ADVANCED GLASS IONOMER (K-130) RESTORATIVE
K101493 · EMA
Dentsply International, Inc.
Dental · 79d
Cleared Aug 19, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · NLH
Sterilmed, Inc.
Cardiovascular · 52d
Cleared Aug 19, 2010
SPI VARIOMULTI ANGLED ABUTMENT
K101798 · NHA
Thommen Medical AG
Dental · 52d
Cleared Aug 19, 2010
STN PROBE
K101816 · ITX
Summit Doppler Systems, Inc.
Radiology · 50d
Cleared Aug 18, 2010
NEONATE ARRAY COILS
K091047 · MOS
Lmt Medical Systems GmbH
Radiology · 492d
Cleared Aug 18, 2010
OSTA MAXIGRO AND REGIGRO
K091424 · NPM
Osta Technologies
Dental · 462d
Cleared Aug 18, 2010
MODULAR ENDOSCOPE
K093785 · GCJ
Sialo Technology, Ltd.
General & Plastic Surgery · 252d
Cleared Aug 18, 2010
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER...
K101152 · GEX
Focus Medical, LLC
General & Plastic Surgery · 117d
Cleared Aug 18, 2010
ZIMMER DTO PIN PRESS INSTRUMENT
K101704 · NQP
Zimmer Spine, Inc.
Orthopedic · 62d
Cleared Aug 18, 2010
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
K101709 · LRK
Steven B. Lamberg, Dds
Dental · 62d
Cleared Aug 17, 2010
LIGAMENTOTAXOR
K094043 · HTY
Arex USA
Orthopedic · 229d
Cleared Aug 17, 2010
HS/HG PROSTHETIC SYSTEM
K100245 · NHA
Osstem Implant Co., Ltd.
Dental · 202d
Cleared Aug 17, 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · KWP
Osteomed LP
Orthopedic · 186d
Cleared Aug 17, 2010
ABREU, MODEL 700
K100843 · FLL
Brain Tunnelgenix Technologies Corp
General Hospital · 145d
Cleared Aug 17, 2010
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED,...
K100975 · LZA
Jiangsu Sunshine Plastic Products,...
General Hospital · 130d
Cleared Aug 17, 2010
HUMAPEN LUXURA HD
K100988 · FMF
Eli Lilly and Company
General Hospital · 130d
Cleared Aug 17, 2010
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
K101038 · KPQ
Acceletronics Digital Imaging, LLC
Radiology · 125d
Cleared Aug 17, 2010
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR)...
K101098 · NUC
Lil Drug Store Products, Inc.
Obstetrics & Gynecology · 119d
Cleared Aug 17, 2010
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
K101241 · NUC
Lil Drug Store Products, Inc.
Obstetrics & Gynecology · 105d
Cleared Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
K101325 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 97d
Cleared Aug 17, 2010
PHARMACARIBE INHALED SALINE SOLUTIONS
K101424 · CAF
Pharmacaribe
Anesthesiology · 89d