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
155881–155904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1983
SHOT GUN KIT FOR CK-MB
K831391 · JHT
Serapine Corp.
Chemistry · 189d
Cleared Nov 03, 1983
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · LDD
Honeywell, Inc.
Cardiovascular · 162d
Cleared Nov 03, 1983
ARF 850 E
K831877 · CBK
W.E. Leder Enterprises, Inc.
Anesthesiology · 143d
Cleared Nov 03, 1983
SURGICAL DRILL-ELECTRIC-HANDPIECE
K831946 · ERL
Entronics
Ear, Nose, Throat · 140d
Cleared Nov 03, 1983
THERMAL DILUTION CATHETER
K832324 · DYG
Catheter Corp. of America
Cardiovascular · 111d
Cleared Nov 03, 1983
SILICONE SOFT-PAK EPISTAXIS CATHETER
K832476 · ENW
Axiom Medical, Inc.
Ear, Nose, Throat · 100d
Cleared Nov 03, 1983
ANGIOSCOPY CATHETER
K832698 · LYK
American Edwards Laboratories
Cardiovascular · 85d
Cleared Nov 03, 1983
STARLYTE
K832744 · JGS
Electro-Nucleonics Laboratories, Inc.
Chemistry · 80d
Cleared Nov 03, 1983
INFUSION PUMP & IV SETS #4000
K832755 · FRN
Omni-Glow, Inc.
General Hospital · 79d
Cleared Nov 03, 1983
ADVANTAGE #1700
K832767 · CCK
The Perkin-Elmer Corp.
Anesthesiology · 79d
Cleared Nov 03, 1983
SATURN-24HR. HOLTER SCANNER
K832772 · DSI
Hittman Medical Systems
Cardiovascular · 79d
Cleared Nov 03, 1983
CORPULS 300
K832827 · LDD
Automated Medical Products, Inc.
Cardiovascular · 73d
Cleared Nov 03, 1983
HEMO-DIAL
K832866 · KPO
Cmi Pharmaceuticals, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 03, 1983
PREGNA-TEC
K832918 · JHJ
Medilab Corp.
Chemistry · 70d
Cleared Nov 03, 1983
AMBULATORY INSULIN INFUSION PUMP
K832923 · FRN
Caridac Pacemakers, Inc.
General Hospital · 71d
Cleared Nov 03, 1983
SERUM IRON & TIBC#65084 & 65085
K833017 · JIY
Emd Chemicals, Inc.
Chemistry · 58d
Cleared Nov 03, 1983
TECHNICON RA-1000 SYSTEM
K833023 · JJC
Technicon Instruments Corp.
Chemistry · 58d
Cleared Nov 03, 1983
INTRAVASCULAR ADMINISTRATION SET
K833030 · FPA
Gish Biomedical, Inc.
General Hospital · 57d
Cleared Nov 03, 1983
CALCIUM DYE REAGENT-CS-718-A/BUFFER
K833035 · CIC
Fisher Scientific Co., LLC
Chemistry · 57d
Cleared Nov 03, 1983
MODEL CD-3A-INCLUDING P-61B SENSOR
K833060 · CCK
Applied Electrochemistry, Inc.
Anesthesiology · 56d
Cleared Nov 03, 1983
TRANSDUCER DOME SD104
K833094 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
TRANSDUCER DOME SD105
K833095 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
TRANSDUCER DOME DS106
K833096 · DRS
Sorensen Research
Cardiovascular · 52d
Cleared Nov 03, 1983
ARGYLE NASAL CANNULA
K833127 · CAT
Sherwood Medical Co.
Anesthesiology · 51d