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
153937–153960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1984
DUAL PURPOSE CATHETER
K833375 · BSY
Jinotti Ent Inc. Medical
Anesthesiology · 135d
Cleared Feb 10, 1984
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K833427 · DXY
Telectronics, Inc.
Cardiovascular · 129d
Cleared Feb 10, 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · DXY
Telectronics, Inc.
Cardiovascular · 129d
Cleared Feb 10, 1984
BLOOD GAS EXPERSYSTEM 8700
K833430 · LLE
Medical Intelcom, Inc.
Neurology · 128d
Cleared Feb 10, 1984
ENDOSCOPIC COUPLER
K833483 · EOQ
Merrimack Laboratories
Ear, Nose, Throat · 126d
Cleared Feb 10, 1984
VZV BIO-ENZABEAD SCREEN KIT
K833637 · LFY
Bionetic Laboratory Products
Immunology · 116d
Cleared Feb 10, 1984
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · ETN
Edward Weck, Inc.
Ear, Nose, Throat · 116d
Cleared Feb 10, 1984
CARDIAC WALL MOTION DEVICE
K833728 · DSB
Intl. Medical, Inc.
Cardiovascular · 108d
Cleared Feb 10, 1984
PERCUTANEOUS RETROGRADE NEPHROSTOMY
K833762 · LJE
Vpi
Gastroenterology & Urology · 107d
Cleared Feb 10, 1984
TRANTECSILICONE QUARTZ DISP. TRANSD
K833792 · DRS
American Bentley
Cardiovascular · 102d
Cleared Feb 10, 1984
ZACT DENTAL ARCH TOOTHBRUSCH
K833815 · EFW
Jfc International, Inc.
Dental · 100d
Cleared Feb 10, 1984
TDK ECG ELECTRODE MEL-08
K833899 · DRX
Tdk Corp.
Cardiovascular · 88d
Cleared Feb 10, 1984
FIXATION PINS
K833952 · HTY
Ethicon, Inc.
Orthopedic · 86d
Cleared Feb 10, 1984
MINATURE PRESSURE TRANSDUCER
K834040 · DXO
Carbomedics, Inc.
Cardiovascular · 79d
Cleared Feb 10, 1984
PHILLY BOLTS
K834148 · GWN
Philadelphia Medical Specialties
Neurology · 86d
Cleared Feb 10, 1984
JAKOBI SURG. INSTRUMENTS #2 70/71
K834193 · FRG
Imm Enterprises , Ltd.
General Hospital · 81d
Cleared Feb 10, 1984
MATERIAL TOOTHSADE RESIN
K834247 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 65d
Cleared Feb 10, 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 60d
Cleared Feb 10, 1984
IM-CHECK
K834345 · KTN
Diagnostic Technology, Inc.
Immunology · 60d
Cleared Feb 10, 1984
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
K834372 · GKL
Diagnostic Technology, Inc.
Hematology · 71d
Cleared Feb 10, 1984
URINARY DRAINAGE CONTAINER
K834448 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 56d
Cleared Feb 10, 1984
ULTROSPEC W/APPLE II -4050-
K834489 · JJQ
Lkb Instruments, Inc.
Chemistry · 70d
Cleared Feb 10, 1984
MODEL M410D HEARING AID
K834523 · ESD
Radioear Corp.
Ear, Nose, Throat · 51d
Cleared Feb 10, 1984
ETHOX WEIGHTED FEEDING TUBE
K834554 · KNT
Ethox Corp.
Gastroenterology & Urology · 45d