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

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176,076 results
77545–77568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL
Nova Biomedical Corp.
Chemistry · 67d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · JFJ
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Jan 15, 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · KRH
St. Jude Medical, Inc.
Cardiovascular · 27d
Cleared Jan 15, 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K014162 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 27d
Cleared Jan 15, 2002
M2376A DEVICELINK SYSTEM, MODEL M2376A
K014181 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 26d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · MKJ
Philips Medical Systems
Cardiovascular · 90d
Cleared Jan 14, 2002
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · KWQ
Scien'Tx USA, Inc.
Orthopedic · 89d
Cleared Jan 14, 2002
NOTTA AMBULATORY RECORDER
K013450 · OLV
Stellate Systems
Neurology · 89d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · KOD
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2002
KAVO POLYLUX II
K013500 · EBZ
Kavo America
Dental · 84d
Cleared Jan 14, 2002
84 CHANNEL EEG
K014146 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
80 CHANNEL EEG
K014147 · GWQ
Xltek
Neurology · 27d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · FPD
Vygon Corp.
Gastroenterology & Urology · 445d
Cleared Jan 11, 2002
SMARTMONITOR 2, MODEL 4000
K011597 · FLS
Respironics Georgia, Inc.
Anesthesiology · 232d
Cleared Jan 11, 2002
RANDOX DIGITOXIN
K012112 · LFM
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Jan 11, 2002
BODYFIX
K013391 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 88d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Jan 11, 2002
ACTAEON PROBE
K013429 · NGR
Osteobiologics, Inc.
Orthopedic · 87d
Cleared Jan 11, 2002
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K013462 · FRO
Hydrofera, LLC
General & Plastic Surgery · 85d
Cleared Jan 11, 2002
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M...
K013598 · DSA
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Jan 11, 2002
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
K014094 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 11, 2002
MODIFICATION TO OUTBACK CATHETER
K014117 · DQY
Lumend, Inc.
Cardiovascular · 28d
Cleared Jan 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · DQY
Abbott Vascular, Inc.
Cardiovascular · 28d