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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72961–72984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2003
INFINTT CO., LTD. STARPACS SYSTEM
K031013 · LLZ
Infinitt Company
Radiology · 17d
Cleared Apr 16, 2003
PANCREATIC DRAINAGE TUBE
K021672 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 330d
Cleared Apr 16, 2003
A/T X-RAY 70
K024285 · EHD
Air Techniques, Inc.
Radiology · 114d
Cleared Apr 16, 2003
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
K030165 · LHQ
Thermatrek
Radiology · 90d
Cleared Apr 16, 2003
IMBIBE II SYRINGE
K030208 · FMF
Orthovita, Inc.
General Hospital · 85d
Cleared Apr 16, 2003
HTS ARRAY COIL
K030540 · MOS
Jockey Club Mri Engineering Center
Radiology · 55d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 16, 2003
ARTHROCARE PERCD SPINEWAND
K030954 · GEI
Arthrocare Corp.
General & Plastic Surgery · 20d
Cleared Apr 15, 2003
DIOLASE 980 D LASER SYSTEM
K023547 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 176d
Cleared Apr 15, 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 15, 2003
GROMAN PREPMASTER
K030292 · KOJ
Groman, Inc.
Dental · 77d
Cleared Apr 15, 2003
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS...
K030385 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 69d
Cleared Apr 15, 2003
BIOUNIVERSAL PKF
K030435 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 15, 2003
BIO UNIVERSAL
K030436 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 14, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 193d
Cleared Apr 14, 2003
L1 SYSTEM
K024170 · FMK
Pelikan Technologies, Inc.
General & Plastic Surgery · 117d
Cleared Apr 14, 2003
VINCO BRAND ACUPUNCTURE NEEDLE
K024207 · MQX
Helio Medical Supplies, Inc.
General Hospital · 115d
Cleared Apr 14, 2003
URINE MONOVETTE BORIC ACID
K024237 · JSM
Sarstedt, Inc.
Microbiology · 112d
Cleared Apr 14, 2003
POLRIS LV
K030186 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d
Cleared Apr 14, 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · GEI
Leonhard Lang GmbH
General & Plastic Surgery · 70d
Cleared Apr 14, 2003
CERACAST-V
K030416 · EJH
Mountain Medico, Inc.
Dental · 63d
Cleared Apr 14, 2003
LINA-BAG, MODELS LB-60, LB-100
K030422 · GCJ
Lina Medical Cml Aps
General & Plastic Surgery · 63d
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · MVO
Phamatech
Toxicology · 62d
Cleared Apr 14, 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · EGS
Pac-Dent International (Suzhou), Ltd.
Dental · 48d