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
140929–140952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1987
MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE
K870021 · KGX
Avery Intl.
General & Plastic Surgery · 34d
Cleared Feb 05, 1987
MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM
K870092 · KGX
Avery Intl.
General & Plastic Surgery · 27d
Cleared Feb 05, 1987
MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM
K870093 · KGX
Avery Intl.
General & Plastic Surgery · 27d
Cleared Feb 05, 1987
IVAC FLOW CONTROL ADMINISTRATION SET
K870132 · LDR
Y
General Hospital · 24d
Cleared Feb 05, 1987
HY PBC FLASK
K870133 · JSG
Hy Laboratories, Ltd.
Microbiology · 24d
Cleared Feb 04, 1987
ACCULATOR 487E
K862352 · GZJ
Accu Science Corp.
Neurology · 229d
Cleared Feb 04, 1987
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · GEX
Laserscope
General & Plastic Surgery · 218d
Cleared Feb 04, 1987
ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
K862610 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 211d
Cleared Feb 04, 1987
TECA/MEDELEC AS-10 SENSOR
K862906 · GWJ
Teca, Inc.
Neurology · 188d
Cleared Feb 04, 1987
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
K863442 · CEP
United Biotech, Inc.
Chemistry · 152d
Cleared Feb 04, 1987
SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE
K863699 · DWL
Hanes Group
General Hospital · 134d
Cleared Feb 04, 1987
CHEMO-CATH INTRAPERITONEAL CATHETER
K863819 · FJS
Hdc Corp.
Gastroenterology & Urology · 127d
Cleared Feb 04, 1987
AMBULATORY INFUSION PUMP, MODEL AS30C
K863864 · FRN
Travenol Laboratories, S.A.
General Hospital · 124d
Cleared Feb 04, 1987
CLYDE (TM) FILTRATION SYSTEM
K864113 · FPB
Arbor Technologies, Inc.
General Hospital · 106d
Cleared Feb 04, 1987
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445 · CHL
Nova Biomedical Corp.
Chemistry · 84d
Cleared Feb 04, 1987
PODOSCOPE
K864499 · IKE
Broadwest Corp.
Physical Medicine · 82d
Cleared Feb 04, 1987
PSORALITE 12800 SERIES
K864510 · FTC
Psoralite Corp.
General & Plastic Surgery · 82d
Cleared Feb 04, 1987
PSORALITE 18400 SERIES
K864511 · FTC
Psoralite Corp.
General & Plastic Surgery · 82d
Cleared Feb 04, 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522 · LBS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Feb 04, 1987
ADX(TM) ANALYZER
K864566 · JJQ
Abbott Laboratories
Chemistry · 77d
Cleared Feb 04, 1987
PODODIGITAL
K864569 · IKE
Broadwest Corp.
Physical Medicine · 76d
Cleared Feb 04, 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Feb 04, 1987
IMMUNO-SURE
K864611
Coulter Electronics, Inc.
Hematology · 72d
Cleared Feb 04, 1987
WHITESIDE ORTHOLOC II METAL BACKED PATELLA
K864627 · JWH
Dow Corning Wright
Orthopedic · 71d