FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131953–131976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1989
HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE
K890484 · FLL
Mallinckrodt Anesthesia Products
General Hospital · 80d
Cleared Apr 21, 1989
SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
K890518 · LJT
Harbor Medical Devices, Inc.
General Hospital · 78d
Cleared Apr 21, 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · BZG
Puritan Bennett Corp.
Anesthesiology · 78d
Cleared Apr 21, 1989
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527 · DTB
Medtronic Vascular
Cardiovascular · 78d
Cleared Apr 21, 1989
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
K890633 · LCO
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
BERICHROM PROTEIN C KIT
K890634 · GGP
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
K890751 · FOZ
Medical Safety Products, Inc.
General Hospital · 67d
Cleared Apr 21, 1989
INFRALASE - LASERGUIDE DELIVERY SYSTEM
K890775 · GEX
Ximed Medical Systems
General & Plastic Surgery · 65d
Cleared Apr 21, 1989
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
K890859 · GFO
Elite Diagnostic , Ltd.
Hematology · 59d
Cleared Apr 21, 1989
INTRAVASCULAR ADMINISTRATION SET
K891072 · FPA
Multi-Med, Inc.
General Hospital · 51d
Cleared Apr 21, 1989
THROMBOSCREEN APTT REAGENT
K891337 · GFO
Pacific Hemostasis
Hematology · 42d
Cleared Apr 21, 1989
EDL ONE-STAGE PROTHROMBIN TIME REAGENT
K891370 · GJS
Elite Diagnostic , Ltd.
Hematology · 43d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · LAS
Bio-Rad
Chemistry · 24d
Cleared Apr 21, 1989
V-TREND TARGET CRP TEST
K892231 · DCN
Texas Immunology, Inc.
Immunology · 17d
Cleared Apr 20, 1989
BELZER UW-CSS
K883782 · KDL
Du Pont Critical Care
Gastroenterology & Urology · 226d
Cleared Apr 20, 1989
SURGICAL 'LASER' DRAPE
K884231 · KKX
Henley Intl.
General Hospital · 195d
Cleared Apr 20, 1989
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200
K884598 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 168d
Cleared Apr 20, 1989
ARISTA AND ORIENT SURGICAL GLOVES
K884633 · KGO
Durante Intl., Inc.
General Hospital · 164d
Cleared Apr 20, 1989
MEDILOG 6000-FD REPORT GENERATOR
K890330 · DSI
Oxford Medilog, Inc.
Cardiovascular · 87d
Cleared Apr 20, 1989
JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES
K890459 · KGO
James River Corp.
General Hospital · 80d
Cleared Apr 20, 1989
OHMEDA 5330 AGENT MONITOR
K890606 · CBQ
Ohmeda Medical
Anesthesiology · 73d
Cleared Apr 20, 1989
RESPIRONICS SEALEASY II
K890795 · BSJ
Respironics, Inc.
Anesthesiology · 62d
Cleared Apr 20, 1989
SLS SIMULATOR (MODELS SLS-9 AND SLS-14)
K891293 · KPQ
Philips Medical Systems North...
Radiology · 41d
Cleared Apr 20, 1989
STERILE SURGEONS' GLOVES
K891621 · KGO
Albors-Menconi Latex Corp.
General Hospital · 34d