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
115777–115800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1992
CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT
K926082 · IZI
Biodan Medical Systems, Ltd.
Radiology · 29d
Cleared Dec 29, 1992
MARQUETTE SV O2 MODULE
K915073 · DQE
Marquette Electronics, Inc.
Cardiovascular · 417d
Cleared Dec 29, 1992
BRAINSCAN RADIOSURGERY MODULE
K920879 · IYE
Brainlab
Radiology · 307d
Cleared Dec 29, 1992
CD4 CYTOSPHERES KIT
K921279 · GKZ
Coulter Electronics, Inc.
Hematology · 287d
Cleared Dec 29, 1992
NATURE'S CRADLE HM-10
K921327 · FMS
Infant Advantage, Inc.
General Hospital · 286d
Cleared Dec 29, 1992
MARQUETTE SERIES 360 DEFIBRILLATOR
K921487 · LDD
Marquette Electronics, Inc.
Cardiovascular · 274d
Cleared Dec 29, 1992
BASIC DRESSING CHANGE TRAY SMP 102A
K922845 · FRG
Specialty Medical Products Co.
General Hospital · 200d
Cleared Dec 29, 1992
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878 · JOH
Bivona Medical Technologies
Anesthesiology · 148d
Cleared Dec 29, 1992
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
K924006 · GNX
Baxter Healthcare Corp
Microbiology · 141d
Cleared Dec 29, 1992
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
K924262 · LLL
The Binding Site, Ltd.
Immunology · 127d
Cleared Dec 29, 1992
MICROWAVE AUTOMATED TISSUE PROCESSOR
K924590 · IEO
Innovative Medical Systems, Inc.
Pathology · 110d
Cleared Dec 29, 1992
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · CEK
Olympus Corp.
Chemistry · 105d
Cleared Dec 29, 1992
KNOT PUSHER
K924728 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 99d
Cleared Dec 29, 1992
FREE SUN PRO DESIGN 3000 AND 3800
K925171 · FTC
Free Sun Prod. AB
General & Plastic Surgery · 76d
Cleared Dec 29, 1992
ACUFEX INTRA ARTICULAR MEASURING DEVICE
K925335 · HTJ
Acufex Microsurgical, Inc.
Orthopedic · 68d
Cleared Dec 28, 1992
SONEX ULTRASONIC TOOTH BRUSH
K913724 · JEQ
Sonex Intl., Corp.
Dental · 496d
Cleared Dec 28, 1992
CENTRA II ANALYSIS SYSTEM
K922171 · DQK
Marquette Electronics, Inc.
Cardiovascular · 234d
Cleared Dec 28, 1992
RUBBER DAM CLAMP
K923163 · EIE
Aseptico, Inc.
Dental · 182d
Cleared Dec 28, 1992
BOSTON CONDITIONING SOLUTION
K923438 · LPN
Polymer Technology Corp.
Ophthalmic · 168d
Cleared Dec 28, 1992
HFG 350, 650, 1050
K923455 · KPR
Varian Canada, Inc.
Radiology · 167d
Cleared Dec 28, 1992
GLUCOSE TEST SYSTEM
K923587 · CGA
Polymer Technology Corp.
Chemistry · 188d
Cleared Dec 28, 1992
ALBUMIN TEST
K923959 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 144d
Cleared Dec 28, 1992
ELECTROPHORESIS TANK
K924020 · JJN
The Binding Site, Ltd.
Chemistry · 139d
Cleared Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
K924113 · DLN
Roche Diagnostic Systems, Inc.
Toxicology · 137d