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
85489–85512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1999
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE...
K984576 · FMI
Terumo Europe N.V.
General Hospital · 173d
Cleared Jun 14, 1999
DEFLECTABLE TAC ELECTROTHERMAL PROBE
K990859 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d
Cleared Jun 14, 1999
HISTOFREEZER DEVICE
K990877 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jun 14, 1999
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
K990956 · DQK
Biosensor Corp.
Cardiovascular · 84d
Cleared Jun 14, 1999
TELEMEDICINE 2000
K991307 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 59d
Cleared Jun 14, 1999
MONOJECT INSULIN SYRINGE
K991758 · FMF
The Kendal Co.
General Hospital · 21d
Cleared Jun 11, 1999
CARDIOLIGHT
K982448 · DSH
Capintec, Inc.
Cardiovascular · 331d
Cleared Jun 11, 1999
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
K983791 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 227d
Cleared Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
K990183 · LZO
Implex Corp.
Orthopedic · 142d
Cleared Jun 11, 1999
COOPERSURGICAL INFRARED COAGULATOR
K990852 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · MND
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Jun 11, 1999
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
K990905 · JOH
Passy-Muir, Inc.
Anesthesiology · 85d
Cleared Jun 11, 1999
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K991002 · FZP
V. Mueller Neuro/Spine
General & Plastic Surgery · 78d
Cleared Jun 11, 1999
MAGNA-ROM 21 KNEE SYSTEEM
K991143 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 11, 1999
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE,...
K991178 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 65d
Cleared Jun 11, 1999
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · EFQ
Symtex Healthcare Corp.
General & Plastic Surgery · 63d
Cleared Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407 · LXT
Synthes (Usa)
Orthopedic · 50d
Cleared Jun 11, 1999
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
K991447 · JJY
Spectral Diagnostics, Inc.
Chemistry · 46d
Cleared Jun 11, 1999
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
K991630 · MDA
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 31d
Cleared Jun 11, 1999
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR...
K991686 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 25d
Cleared Jun 11, 1999
AT HOME DRUG TEST, MODEL 9171
K991824 · MVO
Phamatech
Toxicology · 15d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d
Cleared Jun 11, 1999
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
K991842 · IYO
Ge Vingmed Ultrasound
Radiology · 14d
Cleared Jun 10, 1999
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT...
K980438 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 491d