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

Filters: Cleared only ×
176,076 results
153241–153264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1984
SCANLAN VASCU-STATT II
K841515 · HRG
Scanlan Intl., Inc.
Ophthalmic · 54d
Cleared Jun 05, 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · JHI
Organon, Inc.
Chemistry · 54d
Cleared Jun 05, 1984
AXIOM THORACIC CATHETERS
K841593
Axiom Medical, Inc.
General & Plastic Surgery · 48d
Cleared Jun 05, 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · DQO
Electro-Catheter Corp.
Cardiovascular · 64d
Cleared Jun 05, 1984
TIMEX HEALTHCHECK DIGITAL BP MONITOR
K841616 · DXN
Timex Medical Products Corp.
Cardiovascular · 35d
Cleared Jun 05, 1984
MAXIMAX - 4
K841649 · IZP
Cgr Medical Corp.
Radiology · 46d
Cleared Jun 05, 1984
FLASH GUARD
K841669
Sparco, Inc.
General & Plastic Surgery · 43d
Cleared Jun 05, 1984
LCI MEDICAL INC AIR/PAL
K841728 · FRZ
Lehigh Consolidated Industries
General Hospital · 41d
Cleared Jun 05, 1984
LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM
K841732 · IZP
Sybron Corp.
Radiology · 40d
Cleared Jun 05, 1984
IMPULSE VENTILATOR
K841818 · CBK
Healthdyne, Inc.
Anesthesiology · 35d
Cleared Jun 05, 1984
HPD HUMIDIFIER WICK
K841851 · BTT
Hpd Medical, Inc.
Anesthesiology · 33d
Cleared Jun 05, 1984
THREE WAY INFUSION SET
K841882 · FPA
Med Fusion Systems, Inc.
General Hospital · 29d
Cleared Jun 05, 1984
SURGEON'S BLADES STERILE BLADE
K841883 · GES
An-Med Intl.
General & Plastic Surgery · 29d
Cleared Jun 05, 1984
VMT HAND HELD NEBULIZER
K841894 · CCQ
Vortran Medical Technology 1, Inc.
Anesthesiology · 29d
Cleared Jun 05, 1984
DUPONT ACA LIQUID BILIRUBIN CALIBRATOR
K842222
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH PROCEDURE PACK
K841166 · FMI
Solo Pak Laboratories
General Hospital · 77d
Cleared Jun 04, 1984
SUCTION CANNULAS
K841249 · GEA
Custom Surgical Products, Inc.
General & Plastic Surgery · 75d
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH SOLUTION USP KIT
K841305 · FMI
Solo Pak Laboratories
General Hospital · 66d
Cleared Jun 04, 1984
HEPARIN LOCK FLUSH SOLUTION USP KIT,100
K841306 · FMI
Solo Pak Laboratories
General Hospital · 66d
Cleared Jun 01, 1984
SERVOMED BASIC BEDSIDE UNIT SMA 102-
K832250 · DRT
Litton Medical Electronics
Cardiovascular · 326d
Cleared Jun 01, 1984
2-CHANNEL RECORDER
K832998 · DSF
Litton Medical Electronics
Cardiovascular · 288d
Cleared Jun 01, 1984
I-CHANNEL RECORDER
K833000 · DSF
Litton Medical Electronics
Cardiovascular · 288d
Cleared Jun 01, 1984
EXTENSION BOX EB200
K834530 · DRT
Honeywell, Inc.
Cardiovascular · 163d
Cleared Jun 01, 1984
RECOMB ECG PREAMPLIFIER/206 069 03
K834600 · DRT
Litton Medical Electronics
Cardiovascular · 154d