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
113137–113160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1993
MODEL 480CM INFUSION PUMP, MODIFICATION
K924869 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
MODEL 480CI INFUSION PUMP, MODIFICATION
K924870 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
MODEL 885 INFUSION PUMP, MODIFICATION
K924872 · FRN
3M Health Care, Ltd.
General Hospital · 267d
Cleared Jun 17, 1993
ACUCISE ELECTROSURGICAL TROCAR
K925984 · GEI
Applied Medical Resources
General & Plastic Surgery · 204d
Cleared Jun 17, 1993
MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
K926213 · HSB
Osteo Technology, Inc.
Orthopedic · 189d
Cleared Jun 17, 1993
ALTA CFX ROD SYSTEM
K926232 · HSB
Howmedica Corp.
Orthopedic · 188d
Cleared Jun 17, 1993
LCL 8
K930116 · EMA
Voco GmbH
Dental · 157d
Cleared Jun 17, 1993
ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST
K930614 · DYH
Wallace A. Erickson & Co.
Dental · 132d
Cleared Jun 16, 1993
AIRES
K920043 · CBN
Viva-Tek Assoc., Inc.
Anesthesiology · 527d
Cleared Jun 16, 1993
INSTANT MEMORY 2000
K924187 · DXH
Telescan Medical Systems
Cardiovascular · 300d
Cleared Jun 16, 1993
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
K924193 · BTO
American Healthcare Corp.
Anesthesiology · 300d
Cleared Jun 16, 1993
TRACHEOSTOMY CARE KIT
K924243 · JOH
Transidyne General Corp.
Anesthesiology · 296d
Cleared Jun 16, 1993
WRIGHT POCKET PEAK FLOW METER
K924343 · BZH
Ferraris Medical, Inc.
Anesthesiology · 293d
Cleared Jun 16, 1993
WANDER CARE
K925529 · KMI
Care Electronics, Inc.
General Hospital · 226d
Cleared Jun 16, 1993
SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
K925608 · MFY
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared Jun 16, 1993
KIT, SURGICAL INSTRUMENT, DISPOSABLE
K925905 · KDD
Kay Medical Concepts
General & Plastic Surgery · 210d
Cleared Jun 16, 1993
DATASCOPE MULTINEX ID PLUS
K930303 · CBQ
Datascope Corp.
Anesthesiology · 146d
Cleared Jun 16, 1993
RADIAS TSH ENZYME IMMUNOASSAY
K931061 · JLW
Bio-Rad
Toxicology · 107d
Cleared Jun 16, 1993
DISPOSABLE STEERABLE ANGIOSCOPE
K931421 · LYK
Endovascular, Inc.
Cardiovascular · 86d
Cleared Jun 16, 1993
ABBOTT IMX2 ANALYER
K931970 · JJI
Abbott Laboratories
Chemistry · 55d
Cleared Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067 · DKC
Sigma Diagnostics, Inc.
Toxicology · 48d
Cleared Jun 15, 1993
TES-TAPE
K922207 · CGA
Lilly Research Laboratories
Chemistry · 399d
Cleared Jun 15, 1993
WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
K922407 · LYU
Wells Lamont Corp.
General Hospital · 390d
Cleared Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 363d