FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
112825–112848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1993
AVE ALLIANCE DILATATION CATHETER
K931384 · LIT
Applied Vascular Engineering, Inc.
Cardiovascular · 183d
Cleared Sep 17, 1993
FOG CONTROL, LENS FOG REDUCTION DEVICE
K932300 · OCT
Highpoint Medical Corp.
Gastroenterology & Urology · 128d
Cleared Sep 17, 1993
OLYMPUS CHLORID REAGENT, MODIFIED
K932528 · CHJ
Olympus Corp.
Chemistry · 148d
Cleared Sep 16, 1993
DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC
K914519 · GEX
Dio-Med Corp.
General & Plastic Surgery · 707d
Cleared Sep 16, 1993
THE MINIMED MODEL 404-SP AND 504-S
K922670 · FRN
Medtronic Minimed
General Hospital · 521d
Cleared Sep 16, 1993
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591 · BZR
Merit Medical Systems, Inc.
Anesthesiology · 315d
Cleared Sep 16, 1993
BRANEMARK SYSTEM SCREW TAP
K925768 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Sep 16, 1993
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
K925770 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Sep 16, 1993
BRANEMARK SYSTEM GUIDE PINS
K925772 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Sep 16, 1993
BRANEMARK SYSTEM HAND INSTRUMENT
K925774 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Sep 16, 1993
BRANEMARK SYSTEM MACHINE INST. ACC. TO DRILLING EQ
K925775 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Sep 16, 1993
COLORMARK(TM) VISUALIZATION SYSTEM
K926351 · IYN
Echocath, Inc.
Radiology · 273d
Cleared Sep 16, 1993
MS DISPOSABLE RIGID DOPPLER PROBE
K930227 · DPW
Meadox Medicals, Div. Boston...
Radiology · 240d
Cleared Sep 16, 1993
MODEL 640GE-64: QUADRATURE PELVIC COIL
K930674 · LNH
Medical Advances, Inc.
Radiology · 219d
Cleared Sep 16, 1993
THE INFANT FLOW SYSTEM
K930713 · CAI
Sechrist Industries, Inc.
Anesthesiology · 217d
Cleared Sep 16, 1993
SPRING LOADED SYRINGE
K931095 · FMF
Acacia, Inc.
General Hospital · 197d
Cleared Sep 16, 1993
INMAN POOLE TIP SUCTION PROBE W/TUBING KIT
K933170 · GCY
Inman Medical Corp.
General & Plastic Surgery · 79d
Cleared Sep 15, 1993
APPLICATOR NOZZLE
K926368 · EKJ
Centrix, Inc.
Dental · 267d
Cleared Sep 15, 1993
HELIOSEAL F
K932078 · EBC
Ivoclar North America, Inc.
Dental · 139d
Cleared Sep 15, 1993
CONQUEST CRYSTAL
K932154 · EBF
Jeneric/Pentron, Inc.
Dental · 134d
Cleared Sep 15, 1993
VENTED NEEDLE
K932462 · LHI
Excel Medical, Inc.
General Hospital · 117d
Cleared Sep 15, 1993
BIOMERIEUX HEMOLAB COFAC VIII
K933010 · GJT
Biomerieux Vitek, Inc.
Hematology · 86d
Cleared Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Sep 14, 1993
NASAL/ORAL MASK
K925587 · BZD
Respironics, Inc.
Anesthesiology · 313d