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
68425–68448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2004
RAVEN PROTEST - STEAM
K041386 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 76d
Cleared Aug 09, 2004
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K041492 · DZE
Astra Tech, Inc.
Dental · 66d
Cleared Aug 09, 2004
SENTEC DIGITAL MONITOR MODEL #SDM
K041548 · LKD
Sentec, Inc.
Anesthesiology · 61d
Cleared Aug 09, 2004
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · LLZ
Hologic, Inc.
Radiology · 60d
Cleared Aug 09, 2004
CRYOTIP
K041562 · MQH
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Aug 09, 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND...
K041748 · LCX
Azog, Inc.
Chemistry · 41d
Cleared Aug 09, 2004
PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR
K041831 · MUH
Progeny, Inc.
Radiology · 33d
Cleared Aug 09, 2004
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · GXY
Conmedcorp
Neurology · 20d
Cleared Aug 09, 2004
EMG - ESSENTIAL GAS MODULE, MODEL M1013A
K041956 · CCK
Draeget Medical AG & Co. Kgaa
Anesthesiology · 19d
Cleared Aug 09, 2004
VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
K042028 · LYZ
Zibo Borui Plastic & Rubber Products...
General Hospital · 12d
Cleared Aug 06, 2004
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
K032884 · NFA
Boston Scientific Epi
Cardiovascular · 325d
Cleared Aug 06, 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K040358 · GWF
Excel Tech. , Ltd.
Neurology · 175d
Cleared Aug 06, 2004
POWERHEART AED G3 PRO
K040637 · MKJ
Cardiac Science, Inc.
Cardiovascular · 149d
Cleared Aug 06, 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · DSB
Analogic Corp.
Cardiovascular · 70d
Cleared Aug 06, 2004
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
K041504 · FMF
Haemacure Corp.
General Hospital · 60d
Cleared Aug 06, 2004
LYSUS INFUSION SYSTEM
K041629 · QEY
Ekos Corp.
Cardiovascular · 51d
Cleared Aug 06, 2004
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · DXQ
D. E. Hokanson, Inc.
Cardiovascular · 45d
Cleared Aug 06, 2004
FINISHING WIRE SUPPORTRAK
K041762 · DQX
Guidant Corporation
Cardiovascular · 37d
Cleared Aug 06, 2004
PERMANENT PACING LEAD, MODEL PY2
K041809 · DTB
Oscor, Inc.
Cardiovascular · 31d
Cleared Aug 06, 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · GCJ
Boston Scientific Corp
General & Plastic Surgery · 30d
Cleared Aug 06, 2004
MSI S-500L RF GENERATOR
K041980 · GEI
Medsphere International, Inc.
General & Plastic Surgery · 14d
Cleared Aug 06, 2004
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
K041990 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Aug 06, 2004
DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
K042014 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 10d
Cleared Aug 05, 2004
PLASMAJET SYSTEM
K030819 · GEI
Plasma Surgical, Ltd.
General & Plastic Surgery · 510d