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
45745–45768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2011
BRUX MOUTHGUARDS
K111310 · OBR
Dental Arte, Inc.
Dental · 212d
Cleared Dec 08, 2011
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)
K111646 · MUE
Fujifilm Medical System U.S.A., Inc.
Radiology · 178d
Cleared Dec 08, 2011
SPLIT CATH III
K111651 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 178d
Cleared Dec 08, 2011
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
K111736 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 171d
Cleared Dec 08, 2011
ANGLED TAPERED ABUTMENT
K111853 · NHA
Zimmer Dental, Inc.
Dental · 162d
Cleared Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
K112093 · HRN
Keeler Instruments, Inc.
Ophthalmic · 139d
Cleared Dec 08, 2011
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
K112208 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 129d
Cleared Dec 08, 2011
ZAVATION CERVICAL PLATE SYSTEM
K112533 · KWQ
Zavation, LLC
Orthopedic · 101d
Cleared Dec 08, 2011
MODIFIED ROG SUTURE ANCHOR
K112991 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 63d
Cleared Dec 08, 2011
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
K113111 · NFB
Inovo, Inc.
Anesthesiology · 49d
Cleared Dec 08, 2011
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · FPB
Baxter Healthcare Corp
General Hospital · 37d
Cleared Dec 08, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · KWS
Exactech, Inc.
Orthopedic · 30d
Cleared Dec 07, 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER...
K103544 · NBW
Agamatrix, Inc.
Chemistry · 370d
Cleared Dec 07, 2011
ATHENA PEDICLE SCREW SYSTEM
K110046 · NKB
Royal Oak Medical Devices
Orthopedic · 335d
Cleared Dec 07, 2011
DORNIER MEDILAS D LITEBEAM+ 1470
K110364 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 303d
Cleared Dec 07, 2011
3M TEGADERM MATRIX DRESSING
K110457 · FRO
3M Company
General & Plastic Surgery · 293d
Cleared Dec 07, 2011
NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
K110698 · KGO
Terang Nusa Sdn Bhd
General Hospital · 293d
Cleared Dec 07, 2011
DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
K110924 · GEI
Synergetics, Inc.
General & Plastic Surgery · 247d
Cleared Dec 07, 2011
JOULE CLEARSENSE LASER SYSTEM
K111483 · PDZ
Sciton, Inc
General & Plastic Surgery · 190d
Cleared Dec 07, 2011
DSJ MASSAGER
K112479 · IRP
Mego Afek AC , Ltd.
Physical Medicine · 100d
Cleared Dec 07, 2011
SWIFT FX BELLA
K112489 · BZD
Resmed, Ltd.
Anesthesiology · 100d
Cleared Dec 07, 2011
SEITY 37% PHOSPHORIC ACID ETCHANT GEL
K112597 · KLE
Mycone Dental Supply Co., Inc.
Dental · 91d
Cleared Dec 07, 2011
LARGE/EXTRA LAGRE CONDOM
K113061 · HIS
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 54d
Cleared Dec 07, 2011
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K113179 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 40d