Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
151825–151848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1984
ELECTRO-NERVE STIMULATOR HL
K841184 · GZJ
Biomedical Life Systems, Inc.
Neurology · 198d
Cleared Oct 04, 1984
SERVOMED OXYMONITO SMK 363
K842497 · KLK
Litton Datamedix
Anesthesiology · 100d
Cleared Oct 04, 1984
GUIDELINES FOR PEDIATRIC ANESTHESIA
K842610 · CAC
Critical Care Micro Computing
Anesthesiology · 91d
Cleared Oct 04, 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640 · DSI
Spacelabs, Inc.
Cardiovascular · 86d
Cleared Oct 04, 1984
MAXI-MISER HUMIDIFIER INSERT 1020 & 1021
K842794 · BTT
Nova-Ventrx
Anesthesiology · 79d
Cleared Oct 04, 1984
MAXI-MISER HUMIDIFIER INSERT 1030
K842795 · BTT
Nova-Ventrx
Anesthesiology · 79d
Cleared Oct 04, 1984
CURITY SILICONE NEPHROSTOMY CATHETER
K842840 · LJE
The Kendal Co.
Gastroenterology & Urology · 76d
Cleared Oct 04, 1984
MEDIFLEX DRAINAGE BAG
K843126 · KNX
Mediflex Intl.
Gastroenterology & Urology · 55d
Cleared Oct 04, 1984
SEXTON CYSTOTOMY URINE PUMP
K843158 · KOB
Holter-Hausner Intl.
Gastroenterology & Urology · 55d
Cleared Oct 04, 1984
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
K843198 · FET
Life-Tech Intl., Inc.
Gastroenterology & Urology · 51d
Cleared Oct 04, 1984
NEW ALLERG. COATED MICROFILTER WELL STRI
K843302 · DHB
Diagnostic Reagent Tech.
Immunology · 42d
Cleared Oct 04, 1984
ENCORE HCG REAGENT
K843407 · JHI
Hybritech, Inc.
Chemistry · 34d
Cleared Oct 04, 1984
TUBE-STAT
K843490 · BSR
Concept, Inc.
Anesthesiology · 28d
Cleared Oct 04, 1984
BALLOON DILATION CATHETER
K843501 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Oct 04, 1984
WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
K843520 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 04, 1984
LINDER NASOPHARYNGEAL AIRWAY
K843524 · BTQ
Polamedco, Inc.
Anesthesiology · 28d
Cleared Oct 04, 1984
OHMEDA MODEL 5200 CO2 MONITOR
K843599 · CCK
Ohmeda Medical
Anesthesiology · 22d
Cleared Oct 04, 1984
COTTON TIPPED APPLICATORS, SINGLE
K843720 · KXF
Abco Dealers, Inc.
General Hospital · 10d
Cleared Oct 04, 1984
PNEUPAC INSTANT ACTION VENTILATOR/RESUS
K843737 · CBK
Pneupac , Ltd.
Anesthesiology · 9d
Cleared Oct 04, 1984
OHMEDA RM311 RESPIROMETER
K843799 · BZK
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
OHMEDA RM121 RESPIROMETER
K843800 · BZK
Ohmeda Medical
Anesthesiology · 7d
Cleared Oct 04, 1984
BUNN 3001 OXYGEN CONCENTRATOR
K843811 · CAW
The John Bunn Co.
Anesthesiology · 6d
Cleared Oct 02, 1984
MODELS 78551A 78552A
K841256 · DXG
Hewlett-Packard Co.
Cardiovascular · 214d
Cleared Oct 02, 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · DRT
Aequitron Medical, Inc.
Cardiovascular · 183d