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.

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

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175,820 results
150505–150528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1985
NEPHROSTOMY GUIDEWIRE SHEATH
K845047 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 15d
Cleared Jan 15, 1985
NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
K845048 · LJE
American Edwards Laboratories
Gastroenterology & Urology · 15d
Cleared Jan 14, 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · DXG
American Edwards Laboratories
Cardiovascular · 286d
Cleared Jan 14, 1985
ERYTHROCATH UMBILICAL CATHETER
K841880 · FOZ
Cardio Search, Inc.
General Hospital · 252d
Cleared Jan 14, 1985
LEE SYRINGE
K842371
Peter F. Lee, Inc.
Dental · 213d
Cleared Jan 14, 1985
DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
K842888 · GZJ
Cryomedics, Inc.
Neurology · 175d
Cleared Jan 14, 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · DTN
Shiley, Inc.
Cardiovascular · 150d
Cleared Jan 14, 1985
NUMED BALLOON PACING CATHETER
K843290 · LDF
NuMED, Inc.
Cardiovascular · 146d
Cleared Jan 14, 1985
ADD-A-VIAL SOLUTION TRANSFER DEVICE
K843639 · LHI
American Mcgaw
General Hospital · 119d
Cleared Jan 14, 1985
XENON XE 127/XE 133 GAS DISPENSER
K843640 · IYT
Mallinckrodt Critical Care
Radiology · 119d
Cleared Jan 14, 1985
CASTLE 7515 UTENSIL/GLASSWARE WASHER
K844089 · LDS
Castle Co.
General Hospital · 84d
Cleared Jan 14, 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · FMF
Abco Dealers, Inc.
General Hospital · 83d
Cleared Jan 14, 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · DTN
Gish Biomedical, Inc.
Cardiovascular · 74d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR BCR-2000
K844366 · DTN
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K844367 · DTN
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
FOREGGER DOME VALVES
K844421 · BSZ
Puritan Bennett Corp.
Anesthesiology · 60d
Cleared Jan 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447 · LDD
Datascope Corp.
Cardiovascular · 59d
Cleared Jan 14, 1985
KHM 2000 DRIP WATCHER
K844556 · FLN
The Timeter Group
General Hospital · 54d
Cleared Jan 14, 1985
INFANT LIMB ELECTRODE
K844632 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 48d
Cleared Jan 14, 1985
TRACHEAL TUBE W/AIRWAY INTUBATOR
K844746 · BTR
Sheridan Catheter Corp.
Anesthesiology · 39d
Cleared Jan 14, 1985
SURGICAL DRAPES
K844802 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 34d
Cleared Jan 14, 1985
SECURLINE SURGICAL SKIN MARKER 1000
K844865 · FZZ
Precision Dynamics Corp.
General & Plastic Surgery · 31d
Cleared Jan 14, 1985
FIBERLASE 100 MEDICAL LASER SYSTEM
K844869 · LLO
Laser Media
Anesthesiology · 31d
Cleared Jan 14, 1985
HOLTER CURA-LITE RECORDER
K844977 · DSH
Cardionostics, Inc.
Cardiovascular · 19d