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
141457–141480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1986
MAKLER CATHETER
K863785 · HDR
I M, Inc.
Obstetrics & Gynecology · 76d
Cleared Dec 11, 1986
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902 · DTX
3M Health Care, Sarns
Cardiovascular · 65d
Cleared Dec 11, 1986
STOCKERT-SHILEY CAPS BATTERY MODULE
K863960 · DTQ
Shiley, Inc.
Cardiovascular · 62d
Cleared Dec 11, 1986
BBL CAMPYSLIDE(TM) TEST
K864027 · LQP
Bd Becton Dickinson Vacutainer...
Microbiology · 57d
Cleared Dec 11, 1986
BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR
K864179 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 11, 1986
KOTEX (R) GOODNITES
K864187 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 45d
Cleared Dec 11, 1986
NORFLOXACIN SUSCEPTIBILITY POWDER
K864442 · JTT
Merck, Sharp & Dohme
Microbiology · 29d
Cleared Dec 11, 1986
MODIFIED VSM 2 VITAL SIGNS MONITOR
K864665 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 11, 1986
MODIFIED LIFESTAT 200
K864666 · DXN
Physio-Control Corp.
Cardiovascular · 10d
Cleared Dec 10, 1986
ALT S.C.E. (GPT)
K863053 · CKA
J. D. Assoc.
Chemistry · 120d
Cleared Dec 10, 1986
LDH S.C.E.
K863068 · CFJ
J. D. Assoc.
Chemistry · 120d
Cleared Dec 10, 1986
PROTEINMETER
K863112 · JGP
J. D. Assoc.
Chemistry · 119d
Cleared Dec 10, 1986
MODEL 456 ELECTROCARDIORECORDER RECORDER
K863652 · DPS
Del Mar Avionics
Cardiovascular · 83d
Cleared Dec 10, 1986
TRIOS-M VS-1 PULSE GENERATOR
K863878 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
SEA MED MODEL 6000
K863903 · DTE
Seamed Corp.
Cardiovascular · 64d
Cleared Dec 10, 1986
MODIFIED SODIUM ELECTRODE
K863907 · JGS
Ionetics, Inc.
Chemistry · 64d
Cleared Dec 10, 1986
TUBULICID RED LABEL
K864051 · LBH
Dental Dimensions Supply Co.
Dental · 55d
Cleared Dec 10, 1986
PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
K864121 · NDC
Pharmatrol, Inc.
General Hospital · 50d
Cleared Dec 10, 1986
Q-SCAN II AND Q-SCAN III
K864149 · DSI
Quinton, Inc.
Cardiovascular · 49d
Cleared Dec 09, 1986
CYTOTECH HSV IGG ENZYME IMMUNOASSAY
K862838 · GCO
Cytotech, Inc.
Microbiology · 137d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849 · KHE
Smithkline Diagnostics, Inc.
Hematology · 133d
Cleared Dec 09, 1986
PRESELECTED FLOW RATE I.V. SET
K863304 · FPA
Migada, Ltd.
General Hospital · 106d
Cleared Dec 09, 1986
LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
K864381 · FWC
Luxtec Corp.
General & Plastic Surgery · 34d