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
86257–86280 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1999
DIAMOND II VALVE
K991429 · JXG
Phoenix Biomedical Corp.
Neurology · 23d
Cleared May 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K991460 · MNH
Sofamor Danek
Orthopedic · 22d
Cleared May 19, 1999
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
K991583 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 12d
Cleared May 18, 1999
LAMINOSS DENTAL IMPLANT
K982925 · DZE
Impladent , Ltd.
Dental · 271d
Cleared May 18, 1999
PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
K984022 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 187d
Cleared May 18, 1999
INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
K990493 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 1999
OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
K990509 · EZL
Implemed, Inc.
Gastroenterology & Urology · 89d
Cleared May 18, 1999
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
K990672 · OKS
Hurricane Medical
Ophthalmic · 77d
Cleared May 18, 1999
THE VAULT
K990936 · FMI
Stik Stoppers, Inc.
General Hospital · 60d
Cleared May 18, 1999
MODIFICATION OF:BIODERM FOAM WOUND DRESSING
K990955 · KMF
Bioderm, Inc.
General & Plastic Surgery · 57d
Cleared May 18, 1999
SIGNADRESS DUODERM DRESSING
K990964 · KGN
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 56d
Cleared May 18, 1999
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001...
K991324 · KHJ
Heinz Kurz
Ear, Nose, Throat · 29d
Cleared May 18, 1999
STAPES PROSTHESES
K991394 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 27d
Cleared May 18, 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 11d
Cleared May 17, 1999
CVS PERSONAL LUBRICANT
K983216 · HIS
San-Mar Laboratories, Inc.
Obstetrics & Gynecology · 245d
Cleared May 17, 1999
MANOMETRIC ASSEMBLIES
K983665 · KLA
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 210d
Cleared May 17, 1999
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS...
K983720 · MSE
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 208d
Cleared May 17, 1999
SYNERGY IOM SYSTEM
K984052 · IKN
Oxford Instruments Medical Systems
Neurology · 185d
Cleared May 17, 1999
LATEX EXAMINATION GLOVES (POWDERED)
K984229 · LYY
Sama Kejuruteraan Sdn.Bhd.
General Hospital · 173d
Cleared May 17, 1999
TOTALBOND
K990381 · EMA
Parkell, Inc.
Dental · 98d
Cleared May 17, 1999
ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND...
K990474 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d
Cleared May 17, 1999
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
K990585 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 83d
Cleared May 17, 1999
CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
K990586 · GEI
Conmedcorp
General & Plastic Surgery · 83d
Cleared May 17, 1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 77d