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
84073–84096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1999
IF8000
K991241 · IPF
Dan Med, Inc.
Physical Medicine · 204d
Cleared Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
K991592 · HNI
KARL STORZ Endoscopy-America, Inc.
Ophthalmic · 179d
Cleared Nov 02, 1999
CDTOX A OIA
K991829 · LLH
Biostar, Inc.
Microbiology · 158d
Cleared Nov 02, 1999
THE BRUNO POWERBASE, MODEL PSB-2200
K991954 · ITI
Bruno Independent Living Aids, Inc.
Physical Medicine · 145d
Cleared Nov 02, 1999
SERAQUEST EB NA IGG
K991975 · LSE
Quest Intl., Inc.
Microbiology · 144d
Cleared Nov 02, 1999
TRAY-LINK
K992001 · ELW
Silicon-Und Composite Spezialitaten GmbH
Dental · 140d
Cleared Nov 02, 1999
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
K992310 · IOR
Rupiani Medical
Physical Medicine · 116d
Cleared Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO...
K992492 · GJS
Roche Diagnostics Corp.
Hematology · 99d
Cleared Nov 02, 1999
MITEK MINI ANCHOR
K992623 · DZL
Mitek Products
Dental · 89d
Cleared Nov 02, 1999
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
K992717 · JTN
Pasco Laboratories, Inc.
Microbiology · 82d
Cleared Nov 02, 1999
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE...
K992843 · HAW
Ohio Medical Instrument Co., Inc.
Neurology · 70d
Cleared Nov 02, 1999
WHEELCHAIR (MANUAL, NOT ELECTRICAL)
K992884 · IOR
Foshan Machinery & Equipment Import &...
Physical Medicine · 69d
Cleared Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891 · JDQ
Synthes (Usa)
Orthopedic · 67d
Cleared Nov 02, 1999
BARD HYDROPHILIC COATED GUIDE WIRES
K993000 · DQX
C.R. Bard, Inc.
Cardiovascular · 56d
Cleared Nov 02, 1999
DECAP
K993147 · FPA
The Kipp Group
General Hospital · 42d
Cleared Nov 02, 1999
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
K993517 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Nov 01, 1999
SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
K984203 · IYN
Shantou Institute of Ultrasonic...
Radiology · 342d
Cleared Nov 01, 1999
QUANTECH CK-MB ASSAY
K984433 · MYT
Quantech , Ltd.
Chemistry · 322d
Cleared Nov 01, 1999
ABSOGEL CHEMOTHERAPHY GLOVES
K990677 · LZC
Ampri Rubberware Industries Sdn Bhd
General Hospital · 244d
Cleared Nov 01, 1999
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
K990826 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 234d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · LCP
Abbott Laboratories
Hematology · 187d
Cleared Nov 01, 1999
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · MLD
Datex-Ohmeda, Inc.
Cardiovascular · 112d
Cleared Nov 01, 1999
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION...
K992512 · DZE
Imcor
Dental · 97d
Cleared Nov 01, 1999
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599 · DTN
Dideco S.P.A.
Cardiovascular · 90d