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
47857–47880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2011
HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS...
K102936 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 177d
Cleared Mar 30, 2011
CHLORASHIELD TM ANTIMICROBIAL DRESSING
K103106 · FRO
Care Fusion 213, LLC
General & Plastic Surgery · 161d
Cleared Mar 30, 2011
NEOPAP SYSTEM
K103410 · BZD
Childrens Medical Ventures, LLC
Anesthesiology · 128d
Cleared Mar 30, 2011
IOS FASTSCAN SPRAY
K103586 · ELW
Ios Technnologies, Inc.
Dental · 113d
Cleared Mar 30, 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 83d
Cleared Mar 30, 2011
GAUNYING INFRARED LAMP
K110721 · ILY
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 15d
Cleared Mar 29, 2011
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D,...
K101530 · MUM
Cook Ireland, Ltd.
Gastroenterology & Urology · 299d
Cleared Mar 29, 2011
ELECTRO SENSOR -BODY COMPOSITION
K103026 · MNW
Ld Technology, LLC
Gastroenterology & Urology · 168d
Cleared Mar 29, 2011
DUET DRF
K103038 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 166d
Cleared Mar 29, 2011
ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
K103425 · OWB
Genoray America, Inc.
Radiology · 127d
Cleared Mar 29, 2011
DIGITAL RADIOGRAPHY
K103591 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 112d
Cleared Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 111d
Cleared Mar 29, 2011
BILI-THERAPY SPOT TYPE
K103828 · LBI
Atom Medical Corporation
General Hospital · 91d
Cleared Mar 29, 2011
MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
K110591 · MOS
Mr Instruments, Inc.
Radiology · 27d
Cleared Mar 29, 2011
FLEXIVA TRACTIP
K110685 · GEX
Boston Scientific Corp
General & Plastic Surgery · 18d
Cleared Mar 28, 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 459d
Cleared Mar 28, 2011
CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
K101154 · CAW
Airsep Corp.
Anesthesiology · 339d
Cleared Mar 28, 2011
PANTINO PRO POSITINER
K102521 · LRK
Somnomed, Inc.
Dental · 207d
Cleared Mar 28, 2011
NEW STETIC ACRYLICS
K102874 · EBI
New Stetic
Dental · 179d
Cleared Mar 28, 2011
FX 222-02 POWERED WHEELCHAIR
K110036 · ITI
Lanzhou Wanli Aviation...
Physical Medicine · 82d
Cleared Mar 28, 2011
FIT TEST C&B
K110050 · ELW
Voco GmbH
Dental · 80d
Cleared Mar 28, 2011
ACCUTRAC
K110686 · GEX
Boston Scientific Corp
General & Plastic Surgery · 17d
Cleared Mar 25, 2011
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · MEG
Medline Industries, Inc.
General Hospital · 294d
Cleared Mar 25, 2011
SYNTEC OS SPINAL FIXATION SYSTEM
K101971 · NKB
Syntec Scientific Corp.
Orthopedic · 255d