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
49657–49680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101358 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 102d
Cleared Aug 24, 2010
METAFLEXCOIL
K101632 · MOS
Neocoil, LLC
Radiology · 75d
Cleared Aug 24, 2010
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235 · NKB
Stryker Spine
Orthopedic · 15d
Cleared Aug 23, 2010
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM
K093204 · ILY
Innovative Med, Inc.
Physical Medicine · 314d
Cleared Aug 23, 2010
LUMENVU CATHETER GUIDANCE SYSTEM
K093510 · OMF
Sonosite,Inc.
General Hospital · 284d
Cleared Aug 23, 2010
INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
K093783 · GCJ
Innovia, LLC
General & Plastic Surgery · 257d
Cleared Aug 23, 2010
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
K093916 · NQL
Perkinelmer, Inc.
Chemistry · 244d
Cleared Aug 23, 2010
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
K101068 · NHA
Radiant Express, LLC
Dental · 129d
Cleared Aug 23, 2010
CELL-CHEX
K101335 · GLQ
Streck
Hematology · 103d
Cleared Aug 23, 2010
BEAUTIFIL FLOW PLUS
K101603 · EBF
Shofu Dental Corp.
Dental · 76d
Cleared Aug 23, 2010
LITE ART
K101621 · EBF
Shofu Dental Corp.
Dental · 75d
Cleared Aug 23, 2010
BK BLANK MODEL 20,40,65,90
K101875 · EIH
Bk Medent Co., Ltd.
Dental · 48d
Cleared Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS,...
K102082 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d
Cleared Aug 20, 2010
BBL CHROMAGAR MRSA II
K092767 · JSO
Becton, Dickinson & CO
Microbiology · 345d
Cleared Aug 20, 2010
ZIRCONIA SYRINGE NEEDLE
K093043 · FMI
Kuo Tai Hospital Managements &...
General Hospital · 324d
Cleared Aug 20, 2010
PROCEDURE REHEARSAL STUDIO
K093269 · LLZ
Simbionix , Ltd.
Radiology · 305d
Cleared Aug 20, 2010
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
K093622 · GEI
Encision, Inc.
General & Plastic Surgery · 270d
Cleared Aug 20, 2010
NOBELPROCERA IPS E.MAX CROWN
K100512 · EIH
Nobel Biocare AB
Dental · 179d
Cleared Aug 20, 2010
FLIGHT 60 VENTILATOR, MODEL F-60
K100753 · CBK
Flight Medical , Ltd.
Anesthesiology · 156d
Cleared Aug 20, 2010
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
K101272 · BYJ
Essex Industries, Inc.
Anesthesiology · 106d
Cleared Aug 20, 2010
OSIRIX MD
K101342 · LLZ
Pixmeo Sarl
Radiology · 99d
Cleared Aug 20, 2010
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
K101359 · FMF
Inviro Medical Devices, Inc.
General Hospital · 98d
Cleared Aug 20, 2010
DENTAL HANDPIECES, MODELS: KARAM STD/MINI
K101717 · EFB
Aerobine, Inc.
Dental · 63d
Cleared Aug 19, 2010
BONEOPTIMIZER
K100841 · MQV
Curasan AG
Orthopedic · 147d