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
96217–96240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1996
BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000
K963585 · IYO
Diagnostic Ultrasound Corp.
Radiology · 22d
Cleared Sep 30, 1996
ORLAU SWIVEL WALKER
K923880 · MRI
Mopac, Ltd.
Physical Medicine · 1522d
Cleared Sep 30, 1996
VIRTUOSO SMART CPAP SYSTEM
K953930 · BZD
Respironics, Inc.
Anesthesiology · 406d
Cleared Sep 30, 1996
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 &...
K960055 · LJS
Pudenz-Schulte Medical Research Corp.
General Hospital · 270d
Cleared Sep 30, 1996
ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR
K960301 · GCJ
Del Medical Systems Corp.
General & Plastic Surgery · 252d
Cleared Sep 30, 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K962090 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 124d
Cleared Sep 30, 1996
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
K962360 · MOB
Scimedx Corp.
Immunology · 103d
Cleared Sep 30, 1996
S-52 ELECTRONIC VIDEO LAPAROSCOPE
K962651 · GCJ
Del Medical Systems Corp.
General & Plastic Surgery · 84d
Cleared Sep 30, 1996
HYUNJAE DENTAL IMPRESSION MATERIALS
K962680 · ELW
Hyunjae Corp.
Dental · 82d
Cleared Sep 30, 1996
PULPDENT ENDODONTIC POST CEMENT KIT
K962747 · EMA
Pulpdent Corp.
Dental · 77d
Cleared Sep 30, 1996
IDEAS' DUAL PORT
K962751 · LJT
Ideas For Medicine, Inc.
General Hospital · 77d
Cleared Sep 30, 1996
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG...
K962858 · DXC
Heartport, Inc.
Cardiovascular · 70d
Cleared Sep 30, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K962867 · JWY
Sensititre Alamar
Microbiology · 69d
Cleared Sep 30, 1996
VARELISA ANA (4) PROFILE
K963291 · LJM
Elias U.S.A., Inc.
Immunology · 40d
Cleared Sep 30, 1996
HWA-TO ACUPUNCTURE NEEDLES
K963299 · MQX
Lhasa Medical, Inc.
General Hospital · 40d
Cleared Sep 30, 1996
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · CGX
Sigma Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 27, 1996
MAGLIFE
K950264 · MHX
Odam
Cardiovascular · 613d
Cleared Sep 27, 1996
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · CBK
Ohmeda Medical
Anesthesiology · 200d
Cleared Sep 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 149d
Cleared Sep 27, 1996
QUALITROL ANA CONTROL SERUM SET
K961815 · LKJ
Consolidated Technologies, Inc.
Immunology · 140d
Cleared Sep 27, 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · CEW
Nichols Institute Diagnostics
Chemistry · 126d
Cleared Sep 27, 1996
CUSTOMED BLOOD EXTRACTION KIT
K962596 · GJE
Customed, Inc.
Chemistry · 87d
Cleared Sep 27, 1996
DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM
K962613 · JAD
Gulmay Medical , Ltd.
Radiology · 86d
Cleared Sep 27, 1996
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · CHH
Trace Scientific , Ltd.
Chemistry · 65d