FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94561–94584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · LPH
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 13, 1997
IN-TAC BONE ANCHOR SYSTEM
K964953 · HXJ
Influence, Inc.
Orthopedic · 70d
Cleared Feb 12, 1997
6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE...
K962717 · DQY
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 215d
Cleared Feb 12, 1997
BIONECT CREAM
K963004 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 194d
Cleared Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD...
K963100 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
K963101 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
TROCAR CANNULA
K963115 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 184d
Cleared Feb 12, 1997
BREATHE FIT
K963326 · LWF
Cambridge Assoc.
Ear, Nose, Throat · 173d
Cleared Feb 12, 1997
TRU-PULSE LASER (MODIFIED)
K963683 · GEX
Tissue Technologies, Inc.
General & Plastic Surgery · 167d