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
134689–134712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1988
OPER-FILM-ADHESIVE MEMBRANE
K881936 · NAD
Iberhospitex, S.A.
General & Plastic Surgery · 114d
Cleared Aug 30, 1988
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K875203 · LLM
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 256d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883 · GNP
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · LJN
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885 · GNP
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · LJN
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
DIGITAL MEDICINE ECG MONITOR AND RECORDER
K880971 · DXH
Digital Medicine Systems
Cardiovascular · 175d
Cleared Aug 30, 1988
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
K881494 · HQF
Biophysic Medical, Inc.
Ophthalmic · 144d
Cleared Aug 30, 1988
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 131d
Cleared Aug 30, 1988
NORMAL HUMERAL PROSTHESIS
K881750 · KWS
Osteonics Corp.
Orthopedic · 127d
Cleared Aug 30, 1988
ALPHA-STIM 350
K881753 · GZJ
Electromedical Products, Inc.
Neurology · 131d
Cleared Aug 30, 1988
P.E.E.P. VALVE
K882219 · BYE
Life Support Products, Inc.
Anesthesiology · 96d
Cleared Aug 30, 1988
DC-LIQUICAL CATALOGUE #SE-030
K882258 · JIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 91d
Cleared Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
K882338 · DRO
Cardiotronics, Inc.
Cardiovascular · 85d
Cleared Aug 30, 1988
HARMAC EXTENSION INFUSION SET
K882347 · FPA
Harmac Medical Specialties, Inc.
General Hospital · 84d
Cleared Aug 30, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP
K882393 · DXN
Omron Electronics, Inc.
Cardiovascular · 81d
Cleared Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · GGN
International Technidyne Corp.
Hematology · 75d
Cleared Aug 30, 1988
ANOTRON(R) INCONTINENCE CONTROL SYSTEM
K882555 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 30, 1988
ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
K882687 · LKT
Gull Laboratories, Inc.
Microbiology · 61d
Cleared Aug 30, 1988
MODEL P4/P4X BEHIND-THE-EAR HEARING AID W/PHOX
K882691 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 63d
Cleared Aug 30, 1988
HOUVA-BED
K882722 · FTC
National Biological Corp.
General & Plastic Surgery · 60d
Cleared Aug 30, 1988
L.P.I. LASER DELIVERY SYSTEM
K882738 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 60d