FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
135793–135816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1988
AUDINA
K882004 · ESD
American Audio Services, Inc.
Ear, Nose, Throat · 19d
Cleared May 31, 1988
MODEL 7200A, PRESSURE VENTILATION OPTION
K873151 · CBK
Puritan Bennett Corp.
Anesthesiology · 294d
Cleared May 31, 1988
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
K874663 · BZL
Ametek/Thermox Instruments Division
Anesthesiology · 200d
Cleared May 31, 1988
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
K874664 · DTB
Telectronics, Inc.
Cardiovascular · 200d
Cleared May 31, 1988
ACS FUNNEL INTRODUCER
K875158 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 168d
Cleared May 31, 1988
HORIZON 9000
K875167 · DXG
Mennen Medical, Inc.
Cardiovascular · 167d
Cleared May 31, 1988
TRI-FLOW CATHETER
K875205 · JXG
Neurodynamics, Inc.
Neurology · 165d
Cleared May 31, 1988
PAR(TM) BRAND DRUG OF ABUSE CONTROLS
K880152 · DIF
Medical Analysis Systems, Inc.
Toxicology · 139d
Cleared May 31, 1988
DENVER PERITONEO-VENOUS SHUNT
K880401 · KPM
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 123d
Cleared May 31, 1988
INCOS 50 MASS SPECTROMETER
K880418 · DOP
Finnigan Corp.
Toxicology · 120d
Cleared May 31, 1988
STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II
K880545 · GXY
Stimwear
Neurology · 112d
Cleared May 31, 1988
URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C
K880584 · CDM
Mach Diag. C/O Wichita State University
Chemistry · 111d
Cleared May 31, 1988
THERAPEUTIC DRUG STANDARD
K880705 · DKB
Verichem Laboratories, Inc.
Toxicology · 99d
Cleared May 31, 1988
STERILE NEEDLE FOR BLOOD COLLECTION
K880746 · FMI
Applied Plastics Technology, Inc.
General Hospital · 97d
Cleared May 31, 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823 · KXT
Amersham Corp.
Toxicology · 91d
Cleared May 31, 1988
CONTRAST INJECTION DEVICE
K880877 · DXT
Med-West, Inc.
Cardiovascular · 91d
Cleared May 31, 1988
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
K880930 · HHR
Copper Lasersonics, Inc.
Obstetrics & Gynecology · 88d
Cleared May 31, 1988
SHILEY FEMORAL ARTERIAL CANNULA
K881072 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
SHILEY FEMORAL VENOUS CANNULA
K881074 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
K881088 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 77d
Cleared May 31, 1988
GAMMA GLUTAMYL TRANSFERASE REAGENT SET
K881239 · JPZ
Tech-Neal Scientific, Inc.
Chemistry · 70d
Cleared May 31, 1988
RANEY CLIPS
K881265 · HBO
Zimmer, Inc.
Neurology · 68d
Cleared May 31, 1988
CARDICAD(TM)
K881392 · DWS
Medical/Surgical Specialties, Ltd.
Cardiovascular · 57d
Cleared May 31, 1988
CRANIOTOME BLADE OR NEURO BLADE
K881418 · HBE
Nuell Air Equipment & Hospital...
Neurology · 57d