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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
144529–144552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1986
SALTZMAN STETHOSCOPE HEAD
K854771 · LDE
K & S Medicorp
Cardiovascular · 161d
Cleared May 09, 1986
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731
K854797 · DXN
Takeda Medical, Inc.
Cardiovascular · 158d
Cleared May 09, 1986
MONARK 869 ERGOMETER
K855102 · DSP
Equilibrated Bio Systems, Inc.
Cardiovascular · 137d
Cleared May 09, 1986
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · GZB
Medtronic Vascular
Neurology · 137d
Cleared May 09, 1986
BIOTEL (TM)/UTI
K855238 · JMT
American Diagnostic Corp.
Chemistry · 129d
Cleared May 09, 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124 · KLK
Mennen Medical, Inc.
Anesthesiology · 115d
Cleared May 09, 1986
FASTRACE III, ECG ELECTRODE
K860636 · DPS
Andover Medical, Inc.
Cardiovascular · 77d
Cleared May 09, 1986
HARIKY, MODEL GK-7
K860772 · GZJ
K-Mot, Inc.
Neurology · 67d
Cleared May 09, 1986
ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.)
K861139 · GEI
Conmedcorp
General & Plastic Surgery · 44d
Cleared May 09, 1986
MEDICOMP CPAP NASAL CANNULA
K861280 · BZD
Medicomp, Inc.
Anesthesiology · 32d
Cleared May 09, 1986
SPINNAKER
K861418 · BZC
Cybermedic, Inc.
Anesthesiology · 24d
Cleared May 09, 1986
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · CAI
Vital Signs, Inc.
Anesthesiology · 22d
Cleared May 09, 1986
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
K861559 · DXY
Cook Pacemaker Corp.
Cardiovascular · 14d
Cleared May 09, 1986
NEUROSURGICAL INSTURMENTS (VARIOUS)
K861630 · HAO
Downs Surgical , Ltd.
Neurology · 10d
Cleared May 09, 1986
MICRO-TRACHEOSTOMY CARE KIT
K861645 · BTO
Aci Medical, Inc.
Anesthesiology · 9d
Cleared May 09, 1986
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · CAP
Draeger Medical, Inc.
Anesthesiology · 4d
Cleared May 09, 1986
AS165 RESPIRATION MONITOR
K861743 · BZQ
Air-Shields, Inc.
Anesthesiology · 3d
Cleared May 08, 1986
MEADOS INTRAORTIC GRAFT
K841596 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 750d
Cleared May 08, 1986
RUB E-Z
K854396 · GYA
E-Z Instruments Co.
Neurology · 189d
Cleared May 08, 1986
ECG MONITORING/DEFIBRILLATION ELECTRODE
K854433 · DRX
Andover Medical, Inc.
Cardiovascular · 184d
Cleared May 08, 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · DQY
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared May 08, 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · JOP
Hewlett-Packard Co.
Cardiovascular · 76d
Cleared May 08, 1986
BIOMECCA CARETAKER 1000 & 2000
K860790 · DPS
Biomecca Australia , Ltd.
Cardiovascular · 65d
Cleared May 08, 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
K860805 · DQO
Gould, Inc.
Cardiovascular · 65d