FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84577–84600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1999
OLYMPUS NA-10J-KB ASPIRATION NEEDLE
K991672 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 170d
Cleared Nov 03, 1999
DEVILBISS 5 LITER OXYGEN CONCENTRATOR
K991722 · CAW
Sunrise Medical Hhg, Inc.
Anesthesiology · 167d
Cleared Nov 03, 1999
SIEMENS FIO2 SENSOR
K991884 · CCL
Siemens Medical Solutions USA, Inc.
Anesthesiology · 154d
Cleared Nov 03, 1999
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K992637 · DSI
General Electric Medical Systems...
Cardiovascular · 89d
Cleared Nov 03, 1999
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS...
K992726 · JTN
Pasco Laboratories, Inc.
Microbiology · 82d
Cleared Nov 03, 1999
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Nov 03, 1999
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES),...
K993306 · HAM
Paladin Medical, Inc.
General & Plastic Surgery · 30d
Cleared Nov 02, 1999
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 237d
Cleared Nov 02, 1999
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR...
K991015 · LPL
Lamda Polytech , Ltd.
Ophthalmic · 221d
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