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
143473–143496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1986
BUNN MODEL 510 MEDICATION COMPRESSOR
K862628 · BTI
The John Bunn Co.
Anesthesiology · 28d
Cleared Aug 07, 1986
C.S.M. HIP
K862752
Protek, Inc.
Orthopedic · 16d
Cleared Aug 07, 1986
SILICONE SUMP DRAIN
K862767 · GBS
Sil-Med Corp.
General & Plastic Surgery · 16d
Cleared Aug 07, 1986
SPUNGUARD PLUS SURGICAL DRAPE
K862801 · KKX
Kimberly-Clark Corp.
General Hospital · 15d
Cleared Aug 07, 1986
TEC VARI-TRAC II TRACTION UNIT
K862846 · ITH
Therapeutic Equipment Corp.
Physical Medicine · 9d
Cleared Aug 07, 1986
FRANKLIN CHAIRS/MOVES, #4000 SERIES & #4100 SERIES
K862857 · INO
Franklin Corp.
Physical Medicine · 9d
Cleared Aug 07, 1986
THE TOWERED 90/90 UNIT
K862874 · HST
Lossing Orthopedic, Inc.
Neurology · 8d
Cleared Aug 07, 1986
MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358
K862931 · KNC
Global Medical Prods, Inc.
Obstetrics & Gynecology · 3d
Cleared Aug 06, 1986
S-ROM 135 POROUS COATED FEMORAL STEM COLLAR
K860207
Joint Medical Products Corp.
Orthopedic · 196d
Cleared Aug 06, 1986
CTC 30, 40, 1 LIQUID OXYGEN LITERS
K860738 · BYJ
Cryodyne Technologies, Inc.
Anesthesiology · 160d
Cleared Aug 06, 1986
GEREONICS BIOPOTENTIAL SKIN ELECTRODES
K861099 · DRX
Gereonics, Inc.
Cardiovascular · 135d
Cleared Aug 06, 1986
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD
K861246 · DRX
Conmedcorp
Cardiovascular · 132d
Cleared Aug 06, 1986
DENTAL COTTON ROLLS, STERILE AND NON-STERILE
K861338 · EFN
Intl. Verbandstoff-Fabrik Schaffhau
Dental · 121d
Cleared Aug 06, 1986
NEOGUARD ECG ELECTRODES
K861364 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 117d
Cleared Aug 06, 1986
MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS
K861375 · DXN
Sharp Electronics Corp.
Cardiovascular · 191d
Cleared Aug 06, 1986
COULTER COUNTER MODEL S PLUS JUNIOR
K861780 · GKL
Coulter Electronics, Inc.
Hematology · 90d
Cleared Aug 06, 1986
MINI-TRACH KIT
K862167 · BTO
Portex, Inc.
Anesthesiology · 58d
Cleared Aug 06, 1986
TIMOTHY ALLERGEN DISC
K862174 · DGC
Immuno Nuclear Corp.
Immunology · 58d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313 · LKJ
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Aug 06, 1986
GOULD XCALIBER
K862344 · DRS
Bio-Tek Instruments, Inc.
Cardiovascular · 47d
Cleared Aug 06, 1986
UNI-JET CONNECTOR
K862433 · BZA
Acutronic Medical Systems AG
Anesthesiology · 41d
Cleared Aug 06, 1986
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH
K862544 · DPS
Suzuken Co., Ltd.
Cardiovascular · 34d
Cleared Aug 06, 1986
TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000
K862579 · ITH
Tru-Trac
Physical Medicine · 30d
Cleared Aug 06, 1986
SPERTILITE PHOTOTHERAPY LAMP
K862608 · FTC
Cooper-Hewitt Electric Co.
General & Plastic Surgery · 29d