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
92977–93000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1997
VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
K971837 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 79d
Cleared Aug 06, 1997
ENDOVIEW SPPHIRE LENS SET
K971853 · HJK
American Medical Devices, Inc.
Ophthalmic · 78d
Cleared Aug 06, 1997
AMSINO URINARY LEG BAG
K971929 · KNX
Amsino Intl., Inc.
Gastroenterology & Urology · 71d
Cleared Aug 06, 1997
SMITH & NEPHEW SUTURE COLLET
K971939 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 71d
Cleared Aug 06, 1997
PATIENT RESTRAINT
K971948 · FMQ
E.M. Adams Co., Inc.
General Hospital · 70d
Cleared Aug 06, 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · MFD
A & A Medical, Inc.
Obstetrics & Gynecology · 51d
Cleared Aug 06, 1997
CYTOPLAST REGENTEX TITANIUM 250
K972278 · LYC
Osteogenics Co.
Dental · 49d
Cleared Aug 06, 1997
AQ ONE STEP COCAINE TEST
K972384 · DIO
Bionike Laboratories, Inc.
Toxicology · 41d
Cleared Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · LCQ
Bio-Rad
Hematology · 26d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548 · LYC
Etex Corp.
Dental · 403d
Cleared Aug 05, 1997
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
K963451 · IYE
Topslane
Radiology · 336d
Cleared Aug 05, 1997
AFFINITY BLOOD PUMP SYSTEM
K964017 · DTQ
Avecor Cardiovascular, Inc.
Cardiovascular · 302d
Cleared Aug 05, 1997
MEMORY STAPLE (20 SIZES AVAILABLE)
K964226 · JDR
Landos, Inc.
Orthopedic · 286d
Cleared Aug 05, 1997
ELECTRO-LITE ELITE POWERED WHEELCHAIR
K970575 · ITI
Damaco
Physical Medicine · 173d
Cleared Aug 05, 1997
PM 2002 CC PROLINE
K970812 · EHD
Planmeca Oy
Radiology · 153d
Cleared Aug 05, 1997
40 CC SUMO
K971673 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 05, 1997
UNIGLOVES
K971731 · LYY
Uni-Glove (Usa), Inc.
General Hospital · 88d
Cleared Aug 05, 1997
AMPLAID 460
K971747 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 85d
Cleared Aug 05, 1997
PARI PEP THERAPY SYSTEM
K972042 · BWF
Pari Holding Co.
Anesthesiology · 64d
Cleared Aug 05, 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233 · HWC
Stryker Endoscopy
Orthopedic · 50d
Cleared Aug 05, 1997
V-12 LONG LIFE 675 HEARING AID
K972755 · ESD
Vista Labs
Ear, Nose, Throat · 14d
Cleared Aug 04, 1997
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
K970508 · IYO
Shimadzu Medical Systems
Radiology · 175d