FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95065–95088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1997
OASIS
K964658 · ITX
Sonotech, Inc.
Radiology · 86d
Cleared Feb 14, 1997
SOFTOUCH
K964684 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Feb 14, 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765 · KLT
Chiron Diagnostics Corp.
Toxicology · 79d
Cleared Feb 14, 1997
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 77d
Cleared Feb 14, 1997
PROD. NO. 01-132 - SUTURE REMOVAL KIT
K964827 · MCZ
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 74d
Cleared Feb 14, 1997
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS...
K964955 · OCY
Flexmedics
Gastroenterology & Urology · 65d
Cleared Feb 14, 1997
CYGNUS ELECTROSURGICAL TIP CLEANER
K965086 · GEI
Madison Polymeric Engineering
General & Plastic Surgery · 57d
Cleared Feb 14, 1997
DENTINSENSE B/C
K965138 · KLE
Centrix, Inc.
Dental · 53d
Cleared Feb 14, 1997
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K965201 · LRO
Trinity Laboratories, Inc.
General & Plastic Surgery · 50d
Cleared Feb 14, 1997
BEMIS TWO GALLON SHARPS CONTAINER
K965248 · FMI
Bemis Mfg. Co.
General Hospital · 72d
Cleared Feb 14, 1997
SEALITE SCIENCES AQUALITE FSH
K970085 · CGJ
Sealite Sciences, Inc.
Chemistry · 35d
Cleared Feb 14, 1997
GI SUPPLY PARACENTESIS PUMP
K970186 · BTA
Gi Supply
General & Plastic Surgery · 28d
Cleared Feb 14, 1997
RUNYON LARGE VOLUME PARACENTESIS KIT
K970187 · LRO
Gi Supply
General & Plastic Surgery · 28d
Cleared Feb 14, 1997
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
K970225 · CAK
Alpha Therapeutic Corp.
General Hospital · 28d
Cleared Feb 14, 1997
BENTLEY MANUALLY OPERATED WHEELCHAIR
K970311 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 18d
Cleared Feb 14, 1997
MMB METHOD
K970343 · JHY
Dade Chemistry Systems, Inc.
Chemistry · 16d
Cleared Feb 13, 1997
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K963045 · MNH
Synthes (Usa)
Orthopedic · 192d
Cleared Feb 13, 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · JWH
Zimmer, Inc.
Orthopedic · 184d
Cleared Feb 13, 1997
EMS SWISS LITHOCLAST LITHOTRIPTER
K963285 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 176d
Cleared Feb 13, 1997
PEDIATRIC LIMB HOLDER
K963466 · FMQ
Deroyal Industries, Inc.
General Hospital · 163d
Cleared Feb 13, 1997
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
K963729 · GZJ
Skylark Device Co., Ltd.
Neurology · 150d
Cleared Feb 13, 1997
EXETER MESH
K963940 · JDJ
Howmedica, Inc.
Orthopedic · 135d
Cleared Feb 13, 1997
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Feb 13, 1997
TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR
K964591 · HIS
Line One Laboratories
Obstetrics & Gynecology · 90d