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
167497–167520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1980
CANNULA, W/SHARP OBTURATOR & VERESS NEED
K800668 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 43d
Cleared May 08, 1980
FLO TEM (FLUID WARNER)
K800699 · KZL
Chroma Products, Inc.
Hematology · 41d
Cleared May 08, 1980
TA-641 TINNITUS INSTRUMENT
K800702 · KLW
Audiotrone
Ear, Nose, Throat · 41d
Cleared May 08, 1980
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · FJI
Cordis Corp.
Gastroenterology & Urology · 38d
Cleared May 08, 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · FPA
Travenol Laboratories, S.A.
General Hospital · 38d
Cleared May 08, 1980
ENZYMATIC UREA NITROGEN REAGENT SET REVI
K800719 · CDQ
Macomb Chemical Co.
Chemistry · 38d
Cleared May 08, 1980
GENERAL UTILITY SURG. SCISSORS #460180-
K800721 · HRR
Edward Weck, Inc.
Orthopedic · 37d
Cleared May 08, 1980
EYEWI ANKORS
K800726 · KMK
Eyevi & Co.
General Hospital · 37d
Cleared May 08, 1980
RAPID FERMENTATION AGAR (RFA)
K800734 · JSE
Remel Co.
Microbiology · 36d
Cleared May 08, 1980
STOMAHESIVE STERILE WAFER
K800750 · EXB
Squibb & Sons, Inc.
Gastroenterology & Urology · 34d
Cleared May 08, 1980
RADX VENT-AL MECHANICAL RESPORATOR
K800751 · KPX
Radx Corp.
Radiology · 34d
Cleared May 08, 1980
BOEHRINGER LABS AMBULATORY PEEP VALVE
K800755 · BYE
Boehringer Laboratories
Anesthesiology · 34d
Cleared May 08, 1980
INJECTION SITE, CODE NO. 3100
K800786 · FOZ
Quest Medical, Inc.
General Hospital · 30d
Cleared May 08, 1980
MYERSON R&KENSON R PORCELAIN ANT&POS.-
K800829 · ELL
Myerson Tooth Corp.
Dental · 24d
Cleared May 08, 1980
PY-CO-PROX TM DENTAL BRUSH
K800831 · EFW
Block Drug Company, Inc.
Dental · 24d
Cleared May 08, 1980
ENTELLAN
K800847 · KEP
Mcb Manufacturing Chemists, Inc.
Hematology · 23d
Cleared May 08, 1980
TMS 1000 TEMP. MONITOR & PROBES
K800849 · FLL
Gics Pharmaceuticals
General Hospital · 23d
Cleared May 08, 1980
TIME STEAM AUTOCLAVE TAPE
K800873 · JOJ
Professional Tape Co., Inc.
General Hospital · 21d
Cleared May 08, 1980
PELVIC EXAM TRAY
K800874 · HHD
Pharmaseal Laboratories
Obstetrics & Gynecology · 21d
Cleared May 08, 1980
DISPOSABLE BERMAN AIRWAYS
K800881 · CAE
Harvard Laboratories
Anesthesiology · 21d
Cleared May 08, 1980
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · DEW
Icl Scientific
Immunology · 20d
Cleared May 08, 1980
SIEMENS-ELEMA AB O2-AIR MIXER 960
K800905 · BZR
Siemens Elema AB
Anesthesiology · 17d
Cleared May 08, 1980
NO-BOIL FOLATE KIT #RP-500
K800914 · CGN
Ria Products, Inc.
Chemistry · 17d
Cleared May 08, 1980
P1 BLOOD GROUP SUBSTANCE
K800916 · KSX
Travenol Laboratories, S.A.
Hematology · 16d