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
83497–83520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2000
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
K993395 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993396 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
K993404 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993405 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
K993408 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · JEY
KLS-Martin L.P.
Dental · 68d
Cleared Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
K994159 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 68d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184 · LZO
Biomet, Inc.
Orthopedic · 67d
Cleared Feb 15, 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · JTN
Hardy Diagnostics
Microbiology · 63d
Cleared Feb 14, 2000
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
K000170 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 27d
Cleared Feb 14, 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Feb 14, 2000
NIPRO BLOOD COLLECTION NEEDLE
K992699 · FMI
Nipro Medical Corp.
General Hospital · 186d
Cleared Feb 14, 2000
LCV+ VERSION 2
K993037 · OWB
Ge Medical Systems, Inc.
Radiology · 158d
Cleared Feb 14, 2000
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
K993390 · HIS
Remed Pharma
Obstetrics & Gynecology · 129d
Cleared Feb 14, 2000
GENX CULTURE DISH
K993881 · MQK
Intl., Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 14, 2000
GENX MICROTOOLS
K993884 · MQJ
Intl., Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · JDQ
Whiteside Biomechanics, Inc.
Orthopedic · 90d
Cleared Feb 14, 2000
IDX-60 INTRAORAL X-RAY
K993958 · MUH
X-Cel X-Ray Corp.
Radiology · 84d
Cleared Feb 14, 2000
ISOCENTRIC BEAM CHECKER
K993959 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 84d
Cleared Feb 14, 2000
PERMA-DOC PHANTOM
K993960 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 84d
Cleared Feb 14, 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · FMF
Vascular Technologies , Ltd.
General Hospital · 82d
Cleared Feb 14, 2000
ISSA PHAROS
K994054 · LLZ
Vams Tec, D.O.O.
Radiology · 76d
Cleared Feb 14, 2000
LOCON-T DISTAL RADIAL PLATE
K994061 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 75d
Cleared Feb 14, 2000
MAGNA 5000 PHASED ARRAY CTL SPINE COIL
K994345 · MOS
Usa Instruments, Inc.
Radiology · 53d