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
113737–113760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1993
GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
K930496 · GCI
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 78d
Cleared Apr 20, 1993
LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM
K930569 · GCJ
Laparomed Corp.
General & Plastic Surgery · 89d
Cleared Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
K930845 · DIW
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Apr 20, 1993
VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
K930849 · JPA
Organon Teknika Corp.
Hematology · 61d
Cleared Apr 20, 1993
PULPDENT UNFILLED DUAL CURE BONDING RESIN
K930989 · KLE
Pulpdent Corp.
Dental · 54d
Cleared Apr 20, 1993
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · JHW
Helena Laboratories
Chemistry · 50d
Cleared Apr 19, 1993
E-SP COMBINED EPI SPINAL MINISET
K925014 · CAZ
Neuro Technology
Anesthesiology · 199d
Cleared Apr 19, 1993
KIT PAK URINARY CARE SUPPLIES
K925281 · KNY
Kit Pak, Inc.
Gastroenterology & Urology · 181d
Cleared Apr 19, 1993
ADHESIVE E.T. TAPE
K925386 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 175d
Cleared Apr 19, 1993
MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN.
K925424 · CCK
Medical Manufacturers, Inc.
Anesthesiology · 174d
Cleared Apr 19, 1993
DISPOSABLE CUFFED ENDOTRACHEAL TUBE
K925781 · BTR
Coast Medical Corp.
Anesthesiology · 158d
Cleared Apr 16, 1993
EXCALIBUR ELECTROSURGICAL UNIT
K924960 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 198d
Cleared Apr 16, 1993
TRACET T-6000
K930258 · DRX
Lectec Corp.
Cardiovascular · 87d
Cleared Apr 16, 1993
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
K930690 · DKZ
Solarcare Technologies Corp,Inc.
Toxicology · 65d
Cleared Apr 15, 1993
TENS PRO 900
K915663 · GZJ
Acuhealth (Usa) Pty. , Ltd.
Neurology · 484d
Cleared Apr 15, 1993
XOMED TREACE JET VENTILATION TUBE
K922880 · BTR
Xomed-Treace, Inc.
Anesthesiology · 304d
Cleared Apr 15, 1993
PAJUNK STANDARD SPROTTE NEEDLE W/ INTRODUCER CANN.
K923003 · BSP
Rusch, Inc.
Anesthesiology · 297d
Cleared Apr 15, 1993
SURGILASE FIBERLASE CO2 LASER WAVEGUIDE
K924664 · GEX
Surgilase, Inc.
General & Plastic Surgery · 226d
Cleared Apr 15, 1993
SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES
K925266 · GEI
Laser Surgical Systems
General & Plastic Surgery · 178d
Cleared Apr 15, 1993
ITC BUNJI PLATINUM EMBOLIZATION COIL
K925876 · HCG
Interventional Therapeutics Corp.
Neurology · 147d
Cleared Apr 15, 1993
K-DEFIB/PACE CARBON ELECTRODE
K926175 · DRO
Katecho, Inc.
Cardiovascular · 128d
Cleared Apr 15, 1993
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · GWM
Camino Laboratories, Inc.
Neurology · 90d
Cleared Apr 15, 1993
CAMINO VENTRICULAR ACCESS DEVICE
K930222 · JXG
Camino Laboratories, Inc.
Neurology · 90d
Cleared Apr 14, 1993
STABILITY HIP FEMORAL COMPONENT
K915594 · JDI
Depuy, Inc.
Orthopedic · 488d