FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82417–82440 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 25, 2000
KROM-ALGINATE AND ALGINATE PLUS
K000686 · ELW
Cavex Holland BV
Dental · 86d
Cleared May 25, 2000
IVC TWO MEDIUM
K000937 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 63d
Cleared May 25, 2000
IVC ONE MEDIUM
K000938 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 63d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · JJY
Bio-Rad
Chemistry · 24d
Cleared May 25, 2000
ABBOTT IMX GLYCATED HEMOGLOBIN II
K992085 · LCP
Abbott Laboratories
Hematology · 339d
Cleared May 25, 2000
Q-HTF, CAT# 2001
K993484 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 224d
Cleared May 25, 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
K993777 · HGI
R-Group Intl.
Obstetrics & Gynecology · 199d
Cleared May 25, 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · FIP
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 192d