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

Filters: Cleared only ×
175,820 results
52921–52944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2009
NEWDEAL COMPRESSION PLATE
K091609 · HRS
Newdeal Sas
Orthopedic · 27d
Cleared Jun 30, 2009
HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
K091641 · HCG
MicroVention, Inc.
Neurology · 26d
Cleared Jun 29, 2009
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
K080365 · HET
NOUVAG AG
Obstetrics & Gynecology · 504d
Cleared Jun 29, 2009
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
K083640 · KPR
Choong Wae Medical Corp.
Radiology · 202d
Cleared Jun 29, 2009
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP...
K090126 · GEX
Fotona D.D.
General & Plastic Surgery · 159d
Cleared Jun 29, 2009
CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
K090560 · KCT
Conmed Linvatec
General Hospital · 119d
Cleared Jun 29, 2009
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K090884 · BSO
B.Braun Medical, Inc.
Anesthesiology · 90d
Cleared Jun 29, 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
K090885 · FIP
Nephros, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · NWB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 83d
Cleared Jun 29, 2009
MYRIAN 1.4
K091001 · LLZ
Intrasense
Radiology · 82d
Cleared Jun 29, 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
K091136 · FLE
STERIS Corporation
General Hospital · 70d
Cleared Jun 29, 2009
MR CARDIAC FUNCTION ANALYSIS
K091262 · LLZ
Ziosoft, Inc.
Radiology · 61d
Cleared Jun 29, 2009
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE...
K091325 · KGI
Cooper Surgical
Radiology · 55d
Cleared Jun 29, 2009
CERAMIC PEDATRIC PREFORMED CROWN
K091362 · ELZ
Ez-Pedo, Inc.
Dental · 52d
Cleared Jun 29, 2009
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798,...
K091598 · JAQ
Nucletron Corp.
Radiology · 26d
Cleared Jun 29, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA...
K091658 · OWB
Ge Healthcare
Radiology · 20d
Cleared Jun 26, 2009
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
K083119 · BTR
Smiths Medical Asd, Inc.
Anesthesiology · 247d
Cleared Jun 26, 2009
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
K083256 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 234d
Cleared Jun 26, 2009
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
K083435 · KWS
Arthrex, Inc.
Orthopedic · 218d
Cleared Jun 26, 2009
GUARDIAN 150 ELECTRODE
K083756 · GXY
Selectivemed Components, Inc.
Neurology · 191d
Cleared Jun 26, 2009
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
K090164 · GEX
Biolitec, Inc.
General & Plastic Surgery · 155d
Cleared Jun 26, 2009
ALICE PDX
K090484 · MNR
Respironics Inc., Sleep & Home...
Anesthesiology · 121d
Cleared Jun 26, 2009
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
K090580 · GEI
Solta Medical, Inc.
General & Plastic Surgery · 115d
Cleared Jun 26, 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
K090583 · KGE
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 114d