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

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175,820 results
145729–145752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · DTD
Telectronics, Inc.
Cardiovascular · 62d
Cleared Feb 12, 1986
RATEMINDER III INFUSION DEVICE
K855000 · LDR
American Edwards Laboratories
General Hospital · 61d
Cleared Feb 12, 1986
SWELL-RELIEF
K855004 · DRM
D.A. Schulman, Inc.
Cardiovascular · 61d
Cleared Feb 12, 1986
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · DQK
Marquette Electronics, Inc.
Cardiovascular · 56d
Cleared Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Feb 12, 1986
UPRIGHT BUCKY STAND/MOUNT
K855161 · KPR
X-Ray Systems
Radiology · 48d
Cleared Feb 12, 1986
ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR
K855162 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 48d
Cleared Feb 12, 1986
RONDEX CPR VALVE
K855218 · CBP
Kondex Products, Inc.
Anesthesiology · 44d
Cleared Feb 12, 1986
SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
K860030 · BTA
Surgidyne, Inc.
General & Plastic Surgery · 37d
Cleared Feb 12, 1986
MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
K860102 · FHP
Endotherapeutics
Gastroenterology & Urology · 33d
Cleared Feb 12, 1986
MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE
K860103 · GCP
Endotherapeutics
Gastroenterology & Urology · 33d
Cleared Feb 12, 1986
DOUBLE-JECT TRANSFER NEEDLE
K860113 · LHI
Medimix Products, Inc.
General Hospital · 30d
Cleared Feb 12, 1986
SUM TAN VI
K860144 · FTC
Nae, Inc.
General & Plastic Surgery · 28d
Cleared Feb 12, 1986
BEAVER MICRO-GEM GAUGE BLOCK
K860305 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 15d
Cleared Feb 12, 1986
FYODOROV RADIAL KERATOTOMY MARKER SET
K860329 · HHR
Med-Tech Develoment Corp.
Obstetrics & Gynecology · 14d
Cleared Feb 12, 1986
MAKLAKOV STYLE TONOMETER
K860330 · HKY
Med-Tech Develoment Corp.
Ophthalmic · 14d
Cleared Feb 12, 1986
DISPOSABLE SURGICAL KNIFE
K860331 · HNN
Med-Tech Develoment Corp.
Ophthalmic · 14d
Cleared Feb 12, 1986
SUNLAMP MODELS 24N, 30R, 30RE, 37RE
K860347 · FTC
Gti, Inc.
General & Plastic Surgery · 14d
Cleared Feb 12, 1986
CHEMO-VENT
K860434 · LHI
Intl. Medical Industries
General Hospital · 8d
Cleared Feb 12, 1986
IVAC MODEL 2080 ELECTRONIC THERMOMETER
K860436 · FLL
Y
General Hospital · 8d
Cleared Feb 11, 1986
PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
K854469 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 97d
Cleared Feb 11, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG
K854472 · GEX
Minnesota Laser Corp.
General & Plastic Surgery · 97d
Cleared Feb 11, 1986
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
K854669 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 82d
Cleared Feb 11, 1986
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770 · KWP
Advanced Biosearch Assn.
Orthopedic · 76d