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

Filters: Cleared only ×
175,820 results
144121–144144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1986
MATRIX LR, LR 22A & LR/LASER RECORDER
K860776 · LMC
Matrix Instruments
Radiology · 105d
Cleared Jun 16, 1986
SHUR GEL 4
K860855 · ELW
Columbus Dental Mfg. Co.
Dental · 101d
Cleared Jun 16, 1986
COLOPLAST CONVEX RING
K861070 · EXB
Coloplast A/S
Gastroenterology & Urology · 88d
Cleared Jun 16, 1986
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Jun 16, 1986
FLUORO PLUS
K861279 · LLZ
Advantage Medical Systems, Inc.
Radiology · 70d
Cleared Jun 16, 1986
MILEX BARTHOLIN GLAND CATHETER
K861385 · KNA
Milex Products, Inc.
Obstetrics & Gynecology · 63d
Cleared Jun 16, 1986
SHERIDAN - YSI/ECG SONATEMP (TM)
K861541 · BZT
Sheridan Catheter Corp.
Anesthesiology · 53d
Cleared Jun 16, 1986
TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS
K861552 · KNT
Entech, Inc.
Gastroenterology & Urology · 52d
Cleared Jun 16, 1986
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · CAC
American Pharmaseal Div. Ahsc
Anesthesiology · 46d
Cleared Jun 16, 1986
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 34d
Cleared Jun 16, 1986
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855 · JKF
Sterling Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 16, 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946 · LCX
Healthcheck Corp.
Chemistry · 27d
Cleared Jun 16, 1986
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862067 · LFM
American Dade
Toxicology · 17d
Cleared Jun 16, 1986
MODEL MBA-130 MOBILE X-RAY SYSTEM
K862118 · IZL
Elscint, Inc.
Radiology · 13d
Cleared Jun 16, 1986
SCX SYSTEM
K862120 · JAA
General Electric Co.
Radiology · 13d
Cleared Jun 16, 1986
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · KZJ
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Jun 16, 1986
TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD
K862152 · KJA
Travenol Laboratories, S.A.
Pathology · 13d
Cleared Jun 16, 1986
VENESECTION EQUIPMENT STORAGE TRAY
K862154 · FSM
Rmp Co.
General & Plastic Surgery · 11d
Cleared Jun 13, 1986
EMIT CAFFEINE ASSAY
K853872 · KLS
Syva Co.
Toxicology · 269d
Cleared Jun 13, 1986
COR DOT CMV
K853989 · GQI
Cordis Corp.
Microbiology · 259d
Cleared Jun 13, 1986
INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
K854765 · EHP
C&C Systems, Inc.
Dental · 198d
Cleared Jun 13, 1986
BIOTEL (TM)/ DIABETES
K855239 · JIL
American Diagnostic Corp.
Chemistry · 164d
Cleared Jun 13, 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · DTB
Intermedics, Inc.
Cardiovascular · 120d