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
81841–81864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882 · MHX
Datex-Ohmeda
Cardiovascular · 77d
Cleared Jun 05, 2000
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC)...
K000998 · LPN
Optisonic, Inc.
Ophthalmic · 74d
Cleared Jun 05, 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
K001597 · GCJ
Conmedcorp
General & Plastic Surgery · 13d
Cleared Jun 05, 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · CAF
Apex Medical Corp.
Anesthesiology · 480d
Cleared Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...
K993772 · DTZ
Terumo Medical Corp.
Cardiovascular · 210d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874 · LZO
Plus Orthopedics
Orthopedic · 203d
Cleared Jun 05, 2000
NEPHROSCOPE, 12 DEGREES
K994223 · FGA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 173d
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148 · KHJ
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627 · MNH
Endius, Inc.
Orthopedic · 8d
Cleared Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
K000164 · LPN
Allergan, Inc.
Ophthalmic · 135d
Cleared Jun 02, 2000
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
K001017 · MEG
Retrax Safety Systems, Inc.
General Hospital · 65d
Cleared Jun 02, 2000
AUDIOSCREENER OAE + ABR
K001058 · EWO
Kedly, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 02, 2000
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · JIF
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Jun 02, 2000
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341 · KPR
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · DTB
Biotronik, Inc.
Cardiovascular · 29d
Cleared Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Jun 02, 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · CGA
Selfcare, Inc.
Chemistry · 28d
Cleared Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
K001435 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · JJX
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jun 02, 2000
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 470d
Cleared Jun 02, 2000
XPLORER 1000
K992955 · MQB
Imaging Dynamics Corp.
Radiology · 275d
Cleared Jun 02, 2000
PHARMASEED, MODEL BT-103-2
K993700 · KXK
Syncor International, Inc.
Radiology · 213d
Cleared Jun 02, 2000
OPTIRAD
K993895 · MUJ
Permedics, Inc.
Radiology · 199d