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
49105–49128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2010
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
K102409 · ODC
Byrne Medical, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 04, 2010
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K102500 · KGO
Cardinal Health, Inc.
General Hospital · 64d
Cleared Nov 04, 2010
KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102631 · DXN
Andon Health Co, Ltd.
Cardiovascular · 52d
Cleared Nov 04, 2010
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL...
K102951 · PHX
Exactech, Inc.
Orthopedic · 30d
Cleared Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · JOX
Medtronic, Inc.
Hematology · 31d
Cleared Nov 04, 2010
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2
K102967 · OLO
Smith & Newphew, Inc.
Orthopedic · 30d
Cleared Nov 03, 2010
CLEARFLUX DIALYZER REPROCESSING SYSTEM
K091360 · LIF
Novaflux Technologies
Gastroenterology & Urology · 544d
Cleared Nov 03, 2010
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
K100364 · FJK
Gambro Renal Products, Inc.
Gastroenterology & Urology · 264d
Cleared Nov 03, 2010
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
K100917 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 215d
Cleared Nov 03, 2010
IOLMASTER 500
K101182 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 190d
Cleared Nov 03, 2010
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · FRO
B.Braun Medical, Inc.
General & Plastic Surgery · 120d
Cleared Nov 03, 2010
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)
K102072 · HTY
Memometal Technologies
Orthopedic · 103d
Cleared Nov 03, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102093 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 90d
Cleared Nov 03, 2010
DISCOVERY NM 750B
K102231 · IYX
Ge Medical Systems Israel, Functional...
Radiology · 86d
Cleared Nov 03, 2010
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
K102372 · GEI
Jiangmen City Xinhui Baisheng Medical...
General & Plastic Surgery · 75d
Cleared Nov 03, 2010
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
K102478 · FRO
Southwest Technologies, Inc.
General & Plastic Surgery · 65d
Cleared Nov 03, 2010
SPIDER FLEX MONOPOLAR HOOK
K102646 · GCJ
Transenterix, Inc.
General & Plastic Surgery · 50d
Cleared Nov 03, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K102865 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 34d
Cleared CT Nov 03, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102930 · DXN
Andon Health Co, Ltd.
Cardiovascular · 30d
Cleared Nov 03, 2010
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR
K102994 · FMI
Kawasumi Laboratories, Inc.
General Hospital · 26d
Cleared Nov 02, 2010
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY...
K102074 · LZA
Gx Corporation Sdn Bhd
General Hospital · 99d
Cleared Nov 02, 2010
GRANDIO SO
K102351 · EBF
Voco GmbH
Dental · 75d
Cleared Nov 02, 2010
MUCHECK, VERSION 9.0
K102583 · IYE
Oncology Data Systems, Inc.
Radiology · 55d
Cleared Nov 01, 2010
RANDOX ETHANOL ASSAY
K092273 · DIC
Randox Laboratories, Ltd.
Toxicology · 461d