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

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176,076 results
170905–170928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1978
STOCKINETTE
K781944 · KKX
Kimberly-Clark Corp.
General Hospital · 38d
Cleared Dec 29, 1978
HT-110 MICROMINI
K782076 · DXH
Health Tech
Cardiovascular · 16d
Cleared Dec 29, 1978
MEDTRONIC MODEL 546
K782108 · DTE
Medtronic Vascular
Cardiovascular · 10d
Cleared Dec 28, 1978
GOLD, 24 KARAT CASTING
K781788 · EJT
Williams Gold Refining Co., Inc.
Dental · 70d
Cleared Dec 28, 1978
MODULAT DENTAL SYSTEMS
K781882 · EIA
Vacudent Sales Corp.
Dental · 65d
Cleared Dec 28, 1978
IMPLANT DRIVERS AND TIPS
K781974 · DZJ
Miter, Inc.
Dental · 31d
Cleared Dec 28, 1978
TABLE, EXAMINING-TWO EIGHTY
K782064 · ETF
Amsco Co.
Ear, Nose, Throat · 15d
Cleared Dec 28, 1978
LASER, PHOTOCOAGULATION
K782065 · HQF
Cavitron Corp.
Ophthalmic · 15d
Cleared Dec 27, 1978
SPONGE SYSTEM, ROSERING CONTAIN-COUNT
K782120
Medline Industries, Inc.
General & Plastic Surgery
Cleared Dec 27, 1978
PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT
K782146 · DXY
Arco Medical Products Co.
Cardiovascular
Cleared Dec 26, 1978
MONITOR, SENSOMATIII OXYGEN
K781910 · KLK
Biochem International, Inc.
Anesthesiology · 42d
Cleared Dec 26, 1978
VALVE, AMBU PEEP
K782152 · BYE
Narco Air-Shields
Anesthesiology
Cleared Dec 22, 1978
LITHICRON F PROGRAMMABLE PULSE GEN
K780430 · DXY
Medcor, Inc.
Cardiovascular · 280d
Cleared Dec 22, 1978
MICROLITH A MODEL 703
K782022 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 22, 1978
MICROLITH A MODEL 803
K782023 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 17d
Cleared Dec 22, 1978
MAXI CAMERA 400T
K782029 · IYX
General Electric Co.
Radiology · 17d
Cleared Dec 22, 1978
ELECTRODE LEAD MODEL 030-198
K782097 · DTD
Telectronics, Inc.
Cardiovascular · 4d
Cleared Dec 21, 1978
PACING LEAD MODEL BUS 860, BUS 890
K781624 · DTB
R.E. Brown Co., Inc.
Cardiovascular · 92d
Cleared Dec 21, 1978
PULSTRON MODEL 100
K781835 · DXY
Micro-Rel
Cardiovascular · 52d
Cleared Dec 21, 1978
VENTILATOR, INFANT MODEL 100
K781926 · CBK
Healthdyne, Inc.
Anesthesiology · 43d
Cleared Dec 21, 1978
TRANSMITTER, TR-1 ECG
K782059 · DXH
Burdick Corp.
Cardiovascular · 14d
Cleared Dec 21, 1978
VENTILATOR, MODEL AVA-1, ADULT
K782074 · CBK
Rule Medical Instruments, Inc.
Anesthesiology · 8d
Cleared Dec 20, 1978
CORTRAL I
K780527 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 261d
Cleared Dec 20, 1978
HEMODIALYZER, MODEL RP610, RP AN 69
K781464 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 117d