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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87721–87744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1998
MODIFICATION TO TIELLE HYDROPOLMER DRESSING
K983394 · MGP
Johnson & Johnson Medical, Div. of...
General & Plastic Surgery · 39d
Cleared Nov 03, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K983513 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Nov 03, 1998
MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
K983562 · GKZ
Cdc Technologies, Inc.
Hematology · 21d
Cleared Nov 03, 1998
NEEDLE GUIDE
K983621 · IZH
Remington Medical, Inc.
Radiology · 19d
Cleared Nov 02, 1998
VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K980576 · JAQ
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Nov 02, 1998
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · LYY
Young Innovations, LLC Dba Plak Smacker
General Hospital · 182d
Cleared Nov 02, 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · LYY
Uniject Gloves Pcl
General Hospital · 129d
Cleared Nov 02, 1998
RT DESKTOP
K982713 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 90d
Cleared Nov 02, 1998
SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
K982717 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Nov 02, 1998
9303 NEONATAL/ADULT VITAL SIGNS MONITOR
K982776 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 88d
Cleared Nov 02, 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · FRN
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · MEA
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
K982919 · MOS
Medrad, Inc.
Radiology · 75d
Cleared Nov 02, 1998
MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
K982932 · LNH
Medrad, Inc.
Radiology · 74d
Cleared Nov 02, 1998
CITREX HOSPITAL SPRAY DISINFECTANT
K982985 · LRJ
Caltech Industries, Inc.
General Hospital · 68d
Cleared Nov 02, 1998
PHILIPS DUO DIAGNOST
K983069 · OWB
Philips Medical Systems North...
Radiology · 61d
Cleared Nov 02, 1998
POS-T-VAC (AVP-1000)
K983245 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
POS-T-VAC (IVP-600)
K983246 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
K983619 · FLL
Barchens Co.
General Hospital · 18d
Cleared Oct 30, 1998
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
K973985 · BSZ
Datex-Engstrom, Inc.
Anesthesiology · 375d
Cleared Oct 30, 1998
SILENT NIGHT II
K981034 · MNR
Sleep Solutions, Inc.
Anesthesiology · 225d
Cleared Oct 30, 1998
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX...
K981366 · BTY
Sensor Medics Corp.
Anesthesiology · 198d
Cleared Oct 30, 1998
LTV 1000 VENTILATOR
K981371 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 197d
Cleared Oct 30, 1998
PASTE OPAQUE EX-3
K982766 · EIH
Noritake Co., Inc.
Dental · 85d