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
76705–76728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2002
HENKE SASS WOLF SAPHENOUS VEIN LAPAROSCOPE
K013611 · GCJ
Henke Sass Wolf of America, Inc.
General & Plastic Surgery · 88d
Cleared Feb 01, 2002
TROJAN CRYSTAL CLEAR LIQUID
K013614 · NUC
Armkel, LLC
Obstetrics & Gynecology · 88d
Cleared Feb 01, 2002
SOFTIQUE, MODEL GI 11001
K013707 · IMC
Global TV Concepts, Ltd.
Physical Medicine · 85d
Cleared Feb 01, 2002
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · KPR
Siemens Medical Systems, Inc.
Radiology · 74d
Cleared Feb 01, 2002
TM2000, MODEL 1
K013879 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 70d
Cleared Feb 01, 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · MNI
Blackstone Medical, Inc.
Orthopedic · 70d
Cleared Feb 01, 2002
SCANX
K013893 · MUH
Air Techniques, Inc.
Radiology · 70d
Cleared Feb 01, 2002
BD VACUTAINER SAFETY COAGULATION TUBE
K013971 · JKA
Becton, Dickinson & CO
Hematology · 60d
Cleared Feb 01, 2002
MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX
K013985 · MOS
Machnet BV
Radiology · 60d
Cleared Feb 01, 2002
MODIFICATION TO VIEWSEND MEDICAL
K013994 · LLZ
Klt Telecom, Inc.
Radiology · 59d
Cleared Feb 01, 2002
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · DWC
Minntech Corp.
Cardiovascular · 58d
Cleared Feb 01, 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · CAF
Salter Labs
Anesthesiology · 53d
Cleared Feb 01, 2002
VACUETTE EDTA K2 TUBES
K014104 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
SPECTRAL'S TROPONIN I
K014105 · MMI
Spectral Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
BIOTECH B990K VIVI WHEELCHAIR
K014198 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 42d
Cleared Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · MWI
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Feb 01, 2002
EXS-63 SMALL EXTREMITY ARRAY COIL
K020036 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Feb 01, 2002
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K020070 · EHD
Progeny, Inc.
Radiology · 23d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 18d
Cleared Feb 01, 2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
K020245 · MNH
Scien'Tx USA, Inc.
Orthopedic · 8d
Cleared Jan 31, 2002
HUMPHREY OCT3
K012727 · IYO
Carl Zeiss Ophthalmic Systems, Inc.
Radiology · 169d
Cleared Jan 31, 2002
MATRIX DETACHABLE COILS
K012985 · HCG
Boston Scientific, Target
Neurology · 147d
Cleared Jan 31, 2002
GLOBALCARDIO
K013354 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 31, 2002
NUCLEOTOMY INTRADISCAL CATHETER
K013622 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 87d