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
150961–150984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1984
GAINOR MEDICAL SYRINGE
K844306 · FMF
Gainor Medical
General Hospital · 24d
Cleared Nov 29, 1984
CASABLANCA
K841600 · HIS
Arcon Corp.
Obstetrics & Gynecology · 225d
Cleared Nov 29, 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220 · DXY
Ela Medical, Inc.
Cardiovascular · 177d
Cleared Nov 29, 1984
IREX 730 MECHANICAL SECTOR SCANNER
K842408 · JAF
Irex Corp.
Radiology · 163d
Cleared Nov 29, 1984
EVOKED POTENTIAL SYS
K842543 · GWF
Bio-Logic Systems Corp.
Neurology · 150d
Cleared Nov 29, 1984
AUTOFOCUS DUAL ELEMENT PROBE
K842777 · IYO
Technicare Corp.
Radiology · 136d
Cleared Nov 29, 1984
SURGEON'S GLOVES
K842884 · KGO
Travenol Laboratories, S.A.
General Hospital · 129d
Cleared Nov 29, 1984
WIREGUIDE OR GUIDEWIRE
K843012 · DQX
Medi-Tech, Inc.
Cardiovascular · 121d
Cleared Nov 29, 1984
Q-SCAN THERMOGRAPHY SYSTEM
K843124 · KXZ
Qmax Medical, Inc.
Radiology · 113d
Cleared Nov 29, 1984
EPHAR
K843214 · FFI
Akron City Hospital
Gastroenterology & Urology · 106d
Cleared Nov 29, 1984
ZIMMER BONE CEMENT CENTRIFUGATION SYS
K843219 · JDZ
Zimmer, Inc.
Orthopedic · 106d
Cleared Nov 29, 1984
COROMETRICS 115 FETAL MONITOR
K843385 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 93d
Cleared Nov 29, 1984
3M LASER IMAGER
K843502 · LMC
3M Company
Radiology · 84d
Cleared Nov 29, 1984
FIRM-A-TRON MARK X
K843583 · IPF
Biotron , Ltd.
Physical Medicine · 79d
Cleared Nov 29, 1984
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
K843637 · GZJ
Therapeutic Equipment Corp.
Neurology · 73d
Cleared Nov 29, 1984
CYBEX TORSO TESTING & REHABILITATION
K843739 · IKK
Cybex
Physical Medicine · 65d
Cleared Nov 29, 1984
BACTERIURIA DETECT DEVICE, MULTI SAMPLER
K843833 · JXA
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Nov 29, 1984
BACTERIURIA DETECT. DEVICE APTEK II
K843834 · JXA
Applied Polytechnology, Inc.
Microbiology · 59d
Cleared Nov 29, 1984
EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
K843955 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 51d
Cleared Nov 29, 1984
VISITEC MAGNIFYING SPECTACLES
K844038 · HOI
Visitec Co.
Ophthalmic · 44d
Cleared Nov 29, 1984
UNITED SKIN BARRIERS
K844046 · EXB
Howmedica Corp.
Gastroenterology & Urology · 43d
Cleared Nov 29, 1984
PRUITT IRRIGATION AND OCCLUSION CATHETER
K844094 · GBX
Bionomy, Inc.
General & Plastic Surgery · 42d
Cleared Nov 29, 1984
NUCLEOTOME
K844131 · HSZ
Medical Instrument Development...
Orthopedic · 37d
Cleared Nov 29, 1984
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
K844320
Belgium Surgical Co.
General & Plastic Surgery · 23d