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
139753–139776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1987
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · GNP
Diagnostic Technology, Inc.
Microbiology · 79d
Cleared Jun 25, 1987
MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
K871666 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 58d
Cleared Jun 25, 1987
TX-3(TENS)
K871699 · GZJ
Oms Medico, Inc.
Neurology · 55d
Cleared Jun 25, 1987
POROCOAT MARK II TOTAL ELBOW
K872084 · JDC
Depuy, Inc.
Orthopedic · 27d
Cleared Jun 25, 1987
HAMACHER BULLET POINT OPHTHALMIC NEEDLE
K872200 · HMX
R. J. Doyle, Inc.
Ophthalmic · 17d
Cleared Jun 25, 1987
COOL SHADES
K872218 · HQY
Mattel, Inc.
Ophthalmic · 16d
Cleared Jun 24, 1987
MODEL 600 VASCULAR DUPLEX IMAGER
K863589 · DXK
Multigon Industries, Inc.
Cardiovascular · 282d
Cleared Jun 24, 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · DQY
Gish Biomedical, Inc.
Cardiovascular · 271d
Cleared Jun 24, 1987
PULSE/B.P. MONITOR
K864411 · DXN
Pulse Time Products, Ltd.
Cardiovascular · 229d
Cleared Jun 24, 1987
JUDD URETHAL CATHETER CONTAINER
K864592 · KOD
Phil Judd, Inc.
Gastroenterology & Urology · 215d
Cleared Jun 24, 1987
CATHETER INTRODUCER
K871153 · DYB
Angeion Corp.
Cardiovascular · 92d
Cleared Jun 24, 1987
NORFOLK MEDICAL NORPORT
K871209 · LJT
Norfolk Medical Products, Inc.
General Hospital · 91d
Cleared Jun 24, 1987
DENTI-TRAY(TM)
K871493 · EKW
Advanced Medical, Inc.
Dental · 69d
Cleared Jun 24, 1987
STAT-PAD (TM)
K871538 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 65d
Cleared Jun 24, 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
K871600 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 61d
Cleared Jun 24, 1987
WALLACH CONVERTIBLE COLPOSCOPE
K871682 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 56d
Cleared Jun 24, 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · DSK
A&D Engineering, Inc.
Cardiovascular · 51d
Cleared Jun 24, 1987
COMFORTWEIGH
K871771 · FRW
Curlington Industrial Electronics, Inc.
General Hospital · 49d
Cleared Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
K871775 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Jun 24, 1987
THREE FLUID I.V. SETS
K871841 · FPA
Panamedix, Inc.
General Hospital · 43d
Cleared Jun 24, 1987
TWO FLUID I.V. SETS
K871842 · FPA
Panamedix, Inc.
General Hospital · 43d
Cleared Jun 24, 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · DQA
Puritan Bennett Corp.
Anesthesiology · 42d
Cleared Jun 24, 1987
FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)
K871944 · DSH
Futurecare Systems, Inc.
Cardiovascular · 36d
Cleared Jun 24, 1987
MODIFIED PACE*AID MODEL 53
K871971 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 34d