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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142345–142368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1986
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K862295 · FRN
Imed Corp.
General Hospital · 98d
Cleared Sep 23, 1986
ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K862489 · KNT
Knight Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Sep 23, 1986
HOLLISTER DRAIN TUBE ATTACHMENT
K862573 · KNT
Hollister, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
NEPHROSTOMY DRAINAGE KIT (A-150)
K862580 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
NEPHROSTOMY CONNECTING TUBE (A-50)
K862581 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 23, 1986
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
K862918 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 53d
Cleared Sep 23, 1986
MR620 DUAL SERVO HEATED ANAESTHESIA HUMIDIFIER
K862923 · BTT
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 53d
Cleared Sep 23, 1986
SPACELABS SERIES 90700 PATIENT MONITORS
K862951 · DPS
Spacelabs, Inc.
Cardiovascular · 49d
Cleared Sep 23, 1986
DISPOSABLE MIRROR
K862972
Quali-Med, Inc.
General & Plastic Surgery · 48d
Cleared Sep 23, 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · DQY
Cordis Corp.
Cardiovascular · 56d
Cleared Sep 23, 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · DXT
C.R. Bard, Inc.
Cardiovascular · 42d
Cleared Sep 23, 1986
MEDSENTRY FLOTATION SYSTEM
K863152 · FNM
Medsentry Corp.
General Hospital · 39d
Cleared Sep 23, 1986
TENZCARE SNAP ELECTRODE, NO. 6865
K863307 · GXY
3M Company
Neurology · 29d
Cleared Sep 23, 1986
GRAF CORELLO, POWERED WHEELCHAIR
K863407 · ITI
Graf Products, Inc.
Physical Medicine · 20d
Cleared Sep 23, 1986
ANGIOMED HIGH PRESSURE CONNECTORS
K863446 · GCD
Angiomed U.S., Inc.
General & Plastic Surgery · 15d
Cleared Sep 23, 1986
BIOTRONIK PERMANENT PACEMAKER ELECTRODE
K863480 · DTB
Biotronik Sales, Inc.
Cardiovascular · 14d
Cleared Sep 23, 1986
MEDIFLEX TRANSDUCER PROTECTOR
K863496 · FIB
Mediflex Intl.
Gastroenterology & Urology · 14d
Cleared Sep 23, 1986
URESIL THORACIC VENT
K863561 · KDQ
Uresil Corp.
General Hospital · 11d
Cleared Sep 22, 1986
STEERABLE CATHETER SYSTEM
K862424 · GCP
Endovations
Gastroenterology & Urology · 88d
Cleared Sep 22, 1986
TWIN-CORE
K863031 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 42d
Cleared Sep 22, 1986
ULS 8-86
K863163 · DYN
American Instrument Manufacturer'S, Inc.
Dental · 35d
Cleared Sep 22, 1986
I.V. START KIT
K863284
Welmed Systems, Inc.
General & Plastic Surgery · 28d
Cleared Sep 22, 1986
ESTILUX(R) POSTERIOR C
K863314 · EBF
Kulzer, Inc.
Dental · 27d
Cleared Sep 22, 1986
MULTIFIL(R) VS
K863315 · EBF
Kulzer, Inc.
Dental · 27d