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
83017–83040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · CBF
Environmental Tectonics Corp.
Anesthesiology · 266d
Cleared May 30, 2000
HM-930 ELECTROSURGICAL UNIT
K993991 · GEI
Hill-Med, Inc.
General & Plastic Surgery · 188d
Cleared May 26, 2000
SWIVEL ELBOW
K000215 · BZD
Engineered Medical Systems
Anesthesiology · 123d
Cleared May 26, 2000
DINAMAP ADVANCED NIBP MODULE
K000500 · DXN
Critikon Company, LLC
Cardiovascular · 102d
Cleared May 26, 2000
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
K000669 · GCJ
Medivision Endoscopy
General & Plastic Surgery · 88d
Cleared May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 88d
Cleared May 26, 2000
WHEELCHAIR, MODELS H001A, 4422
K000738 · IOR
Jackson Company, LLC
Physical Medicine · 80d
Cleared May 26, 2000
RIGID GAS PERMEABLE CONTACT LENS
K000795 · HQD
Polymer Technology
Ophthalmic · 74d
Cleared May 26, 2000
SPIRAL IMAGING OPTION
K000802 · LNH
GE Medical Systems
Radiology · 74d
Cleared May 26, 2000
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
K000960 · IYO
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 63d
Cleared May 26, 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · JPA
Dade Behring, Inc.
Hematology · 60d
Cleared May 26, 2000
LIBERTY 9000 BREAST COIL
K000993 · MOS
Usa Instruments, Inc.
Radiology · 59d
Cleared May 26, 2000
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K001203 · ITX
The Olympus Optical Co.
Radiology · 43d
Cleared May 26, 2000
SURGITRON IEC II
K001253 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 37d
Cleared May 26, 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315 · BSZ
Siemens Elema AB
Anesthesiology · 30d
Cleared May 26, 2000
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
K001397 · DKZ
Phamatech
Toxicology · 23d
Cleared May 26, 2000
OPTIMUM WETTING AND REWETTING DROP
K001428 · MRC
Lobob Laboratories, Inc.
Ophthalmic · 21d
Cleared May 26, 2000
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K001429 · KGI
Schick Technologies, Inc.
Radiology · 21d
Cleared May 26, 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
K992668 · DYB
Innerdyne, Inc.
Cardiovascular · 291d
Cleared May 26, 2000
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K994260 · GEX
Candela Corp.
General & Plastic Surgery · 161d
Cleared May 26, 2000
IIVS INTEGRATED IMAGE VIEWING STATION
K994329 · LMD
Terarecon,Inc.
Radiology · 156d
Cleared May 25, 2000
SYNTHETIC GLASS BONE GRAFT MATERIAL
K000633 · LYC
Blue Sky Bio
Dental · 90d
Cleared May 25, 2000
VISIONARY 2000
K000639 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 90d
Cleared May 25, 2000
VISION ESTHETIC PORCELAIN SYSTEM
K000680 · EIH
Midatlantic Division of Dentrex, Inc.
Dental · 86d