Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77305–77328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2002
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K014077 · LZA
Shijiazhuang Great Vision Plastic...
General Hospital · 55d
Cleared Feb 04, 2002
DEMETRON LC
K014179 · EBZ
Kerr Corp.
Dental · 46d
Cleared Feb 04, 2002
pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
K020148 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 19d
Cleared Feb 01, 2002
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
K011901 · MKJ
Survivalink Corp.
Cardiovascular · 228d
Cleared Feb 01, 2002
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K012241 · DSI
Cardionet, Inc.
Cardiovascular · 199d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 193d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · JJF
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Feb 01, 2002
XENALIGHT MODELS # AX9125 (100-120V~)
K013511 · FSW
Aculux, Inc.
General & Plastic Surgery · 102d
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