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
134089–134112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1988
GRID/RADIOGRAPHIC
K883527 · IXJ
Umi, Inc.
Radiology · 15d
Cleared Sep 02, 1988
LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
K883599 · IEO
Innovative Medical Systems, Inc.
Pathology · 10d
Cleared Sep 01, 1988
SYRINGE PUMP MS2000
K880857 · FRN
Smash Ent., Inc.
General Hospital · 184d
Cleared Sep 01, 1988
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878 · IYX
Philips Medical Systems (Cleveland),...
Radiology · 184d
Cleared Sep 01, 1988
EXPANDED CLAIMES TO OSTEOGEN(R)
K881662 · DZE
Impladent
Dental · 139d
Cleared Sep 01, 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · CAC
Sherwood Medical Co.
Anesthesiology · 58d
Cleared Sep 01, 1988
HEARING AID, UNITRON MODEL VISTA 1000
K883513 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 31, 1988
AD-HEAL(TM) WOUND DRESSING
K881731 · NAD
Nepera, Inc.
General & Plastic Surgery · 131d
Cleared Aug 31, 1988
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
K881779 · HSX
Dow Corning Wright
Orthopedic · 127d
Cleared Aug 31, 1988
TRACER
K881842 · BXN
Life-Tech Intl., Inc.
Anesthesiology · 121d
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