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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133561–133584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 1988
DIACARE MONITORING SYSTEM
K882001 · NDC
Healthware Corp.
General Hospital · 159d
Cleared Oct 18, 1988
NICOLET EPIDURAL SPINAL ELECTRODE
K882053 · GYC
Nicolet Instrument Corp.
Neurology · 155d
Cleared Oct 18, 1988
NEBULIZER PUMP POWERED MODELS 020 AND 050
K883132 · BTI
Travelneb, Inc.
Anesthesiology · 84d
Cleared Oct 18, 1988
DISPOSABLE AMNIOTOME
K883283 · HGG
Galenica Enterprises, Inc.
Obstetrics & Gynecology · 75d
Cleared Oct 18, 1988
LUMINBOND, BONDING AND CEMENTATION SYSTEM
K883392 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 70d
Cleared Oct 18, 1988
CLOSED WOUND SUCTION DEVICE
K883472 · GCY
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 63d
Cleared Oct 18, 1988
ULTRACARE
K883633 · DWL
Jobst Institute, Inc.
General Hospital · 54d
Cleared Oct 18, 1988
QUIDEL ALLERGY SCREEN
K883666 · DHB
Quidel Corp.
Immunology · 53d
Cleared Oct 18, 1988
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
K883719 · LQJ
Biophysic Medical, Inc.
Ophthalmic · 48d
Cleared Oct 18, 1988
ARTERIAL ANCHOR BANDAGE
K883957 · FMK
Guidelines, Inc.
General & Plastic Surgery · 29d
Cleared Oct 17, 1988
DANTEC MAGNETIC STIMULATOR
K881915 · GWF
Dantec Electronics, Inc.
Neurology · 161d
Cleared Oct 17, 1988
CARDIOMEGA-T
K883410 · DSI
Grandcor Medical Systems
Cardiovascular · 67d
Cleared Oct 17, 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · DXO
Ppg Industries, Inc.
Cardiovascular · 63d
Cleared Oct 17, 1988
BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P
K883819 · CCW
Circon Acmi
Anesthesiology · 39d
Cleared Oct 17, 1988
SINGLE-FIL(TM) SYRINGE
K883955 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 28d
Cleared Oct 17, 1988
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
K884023 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 25d
Cleared Oct 17, 1988
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
K884211 · FMI
Marquette Medical, Inc.
General Hospital · 11d
Cleared Oct 17, 1988
WINGED NON-CORING NEEDLE SET
K884212 · FMI
Marquette Medical, Inc.
General Hospital · 11d
Cleared Oct 14, 1988
AIR PLETHYSMOGRAPH MODEL APG-1000
K881291 · DSB
Aci Medical, Inc.
Cardiovascular · 200d
Cleared Oct 14, 1988
PIPELLE DE CORNIER ENDOMETRIAL SUCTION CURETTE
K881456 · HHK
Laboratoire Ccd C/O Washington...
Obstetrics & Gynecology · 191d
Cleared Oct 14, 1988
BLOOD PRESSURE CUFF
K881799 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 170d
Cleared Oct 14, 1988
ULTRAFLOTATION BED
K882607 · IOQ
Medical Flotation Systems, Inc.
Physical Medicine · 112d
Cleared Oct 14, 1988
TOWNLEY COX COMB ACETABULAR COMPONENT
K882869 · JDI
Biopro, Inc.
Orthopedic · 95d
Cleared Oct 14, 1988
MULTI-DRUG INFUSION SYSTEM
K883003 · FRN
I-Flow Corp.
General Hospital · 88d