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
154945–154968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1984
THIOGLYCOLLATE MEDIUM TUBE
K840077 · JSG
Otisville Biotech, Inc.
Microbiology · 25d
Cleared Feb 01, 1984
EVERTAN SUNTAN BEDS
K834493 · FTC
Oregon Beauty Supply
General & Plastic Surgery · 64d
Cleared Jan 31, 1984
GEN. PURPOSE INSTRUMENT TRAYS &
K833058 · FSM
Inter-Med Corp.
General & Plastic Surgery · 145d
Cleared Jan 31, 1984
AGC TOTAL KNEE PROSTHESIS
K833921 · JWH
Biomet, Inc.
Orthopedic · 78d
Cleared Jan 31, 1984
ANA TRANS TUBE & SWABS STERILE PACK
K834357 · JSL
Anaerobe Systems
Microbiology · 49d
Cleared Jan 31, 1984
SALON -BODY TANNING BED
K834492 · FTC
Grantan
General & Plastic Surgery · 62d
Cleared Jan 30, 1984
STERILE DISPOSABLE SURGICAL GLOVES
K830635
Intermarket Latex, Inc.
General & Plastic Surgery · 335d
Cleared Jan 30, 1984
MODEL 150K LASER COAGULATOR
K832089 · HQF
Lasertek OY
Ophthalmic · 221d
Cleared Jan 30, 1984
OPHTHALMIC ARGON LASER #700A
K832316 · HQF
Laser Industries , Ltd.
Ophthalmic · 199d
Cleared Jan 30, 1984
VYGON THORACIC DRAINAGE-VARIOUS #'S
K832628 · KDD
Exco, Inc.
General & Plastic Surgery · 179d
Cleared Jan 30, 1984
ARGON LASER SYS-MODEL 5000
K832703 · HQE
Cooper Medical Corp.
Ophthalmic · 172d
Cleared Jan 30, 1984
BREAST & BODY HEALTH SYSTEM 2000
K832731 · KXZ
American Thermal Instruments, Inc.
Radiology · 179d
Cleared Jan 30, 1984
LIFEPAK 7P
K832876 · DRO
Physio-Control Corp.
Cardiovascular · 157d
Cleared Jan 30, 1984
HYPAL ADHESIVE TAPE
K832991 · KQX
Smith & Nephew, Inc.
Neurology · 150d
Cleared Jan 30, 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142 · CDD
Bd Becton Dickinson Vacutainer...
Chemistry · 138d
Cleared Jan 30, 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · JOQ
Medtronic Vascular
Cardiovascular · 119d
Cleared Jan 30, 1984
DPC GASTRIN KIT
K833489 · CGC
Diagnostic Products Corp.
Chemistry · 115d
Cleared Jan 30, 1984
PULSE GENERATOR MODEL 688
K833519 · DXY
Burditt & Calkins-Siemens-Elema
Cardiovascular · 111d
Cleared Jan 30, 1984
LASER PHOTOCOAGULATOR 1520-A & K
K833533 · HQF
Britt Corp., Inc.
Ophthalmic · 111d
Cleared Jan 30, 1984
COMFEEL PASTE
K833565 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
COLOPLAST BABY URINE COLLECTORS
K833570 · KNX
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
STERILE DRAINAGE SYSTEM
K833571 · EXB
Coloplast A/S
Gastroenterology & Urology · 110d
Cleared Jan 30, 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · DYG
Critikon Company, LLC
Cardiovascular · 110d
Cleared Jan 30, 1984
VERIFORM II
K833583 · DXN
American Medical Systems, Inc.
Cardiovascular · 110d