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
139729–139752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1987
STIMULATOR, ULTRASOUND AND MUSCLE
K871647 · IMG
Amy West
Physical Medicine · 62d
Cleared Jun 29, 1987
MECONIUM SUCTION CATHETER
K871825 · BSY
Concord Laboratories, Inc.
Anesthesiology · 49d
Cleared Jun 29, 1987
PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
K871826 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 49d
Cleared Jun 29, 1987
LECTEC NON-INVASIVE PACING ELECTRODE
K872012 · DRO
Lectec Corp.
Cardiovascular · 34d
Cleared Jun 29, 1987
VENTRESCREEN (TM) MONO
K872032 · KTN
Ventrex Laboratories, Inc.
Immunology · 33d
Cleared Jun 26, 1987
ENTERAL ADMINISTRATION SET
K870623 · FPD
Plasco, Inc.
Gastroenterology & Urology · 134d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2
K871228 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
K871229 · GOD
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS
K871230 · LKT
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
K871231 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3
K871232 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A
K871233 · GNX
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1
K871234 · GQS
Microscan Div. Baxter Healthcare Corp.
Microbiology · 91d
Cleared Jun 26, 1987
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552 · HHT
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 65d
Cleared Jun 26, 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · FRO
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 51d
Cleared Jun 26, 1987
HOT/ICE DUAL FUNCTION EQUIPMENT
K871962 · ILO
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Jun 26, 1987
HOT/ICE DISPOSABLE BLANKET
K871963 · ILO
Thermo Temp, Inc.
Physical Medicine · 37d
Cleared Jun 26, 1987
ELASTO-GEL OCCLUSIVE DRESSING
K872165 · FRO
Southwest Technologies, Inc.
General & Plastic Surgery · 21d
Cleared Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · KTT
Howmedica Corp.
Orthopedic · 17d
Cleared Jun 26, 1987
VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
K872271 · GEN
New England Surgical Instrument Corp.
General & Plastic Surgery · 14d
Cleared Jun 25, 1987
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · DQY
Gish Biomedical, Inc.
Cardiovascular · 272d
Cleared Jun 25, 1987
THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866 · FPA
Pharmacia, Inc.
General Hospital · 114d
Cleared Jun 25, 1987
HUNTLEIGH FLOWPAC FP2000
K871272 · DRM
Huntleigh Technology, Inc.
Cardiovascular · 86d
Cleared Jun 25, 1987
EBNA ACIF ASSAY KIT
K871298 · LLM
Granbio, Inc.
Microbiology · 86d