FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135505–135528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1988
TOTAL PROTEIN/ALBUMIN STANDARD
K882116 · JIX
Verichem Laboratories, Inc.
Chemistry · 36d
Cleared Jun 24, 1988
SARACAP AG
K882172 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 31d
Cleared Jun 24, 1988
DELFIA ESTRADIOL KIT
K882173 · CHP
Pharmacia, Inc.
Chemistry · 31d
Cleared Jun 24, 1988
MODEL 172-P AND 172-N ROTARY SPRAY ARM
K882465 · FLE
Boling Precision Components Co.
General Hospital · 9d
Cleared Jun 23, 1988
EUB-450 DIAGNOSTIC ULTRASOUND DEVICE
K874211 · IYO
Hitachi Medical Corp. of America
Radiology · 251d
Cleared Jun 23, 1988
TITANIUM BACKSTOP WITH SUCTION
K874611 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
TITANIUM RODS
K874612 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
SUCTION AND LAVAGE PROBE
K874614 · HET
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
LASER CANNISTER FILTER
K874615 · HHR
Medical Marketing, Inc.
Obstetrics & Gynecology · 227d
Cleared Jun 23, 1988
TDP, LARK BRAND AND MIT LAMP
K875052 · ILY
I.E.C. Co.
Physical Medicine · 197d
Cleared Jun 23, 1988
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN
K880382 · FYA
Kimberly-Clark Corp.
General Hospital · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON
K880383 · FYA
Kimberly-Clark Corp.
General Hospital · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT
K880384 · BWP
Kimberly-Clark Corp.
General & Plastic Surgery · 147d
Cleared Jun 23, 1988
KIMBERLY-CLARK PROTECTIVE SLEEVE
K880386 · FYA
Kimberly-Clark Corp.
General Hospital · 147d
Cleared Jun 23, 1988
SYRINGE PREFILLED WITH WATER
K881363 · KOD
I M, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 23, 1988
CPR BAG
K881686 · BTM
Devolve Corp.
Anesthesiology · 65d
Cleared Jun 23, 1988
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
K881695 · LFJ
Deseret Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Jun 23, 1988
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER
K881743 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 23, 1988
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
K882244 · EPP
Richards Medical Co., Inc.
Ear, Nose, Throat · 23d
Cleared Jun 23, 1988
STORZ DIAGNOSTIC MICROSCOPE SYSTEM
K882269 · EPT
Storz Instrument Co.
General & Plastic Surgery · 23d
Cleared Jun 23, 1988
COVER, SHOE OPERATING ROOM
K882280 · FXP
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
GOWN, ISOLATION, SURGICAL (FYC)
K882281 · FYC
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
SUIT, SURGICAL
K882282 · FXO
A Plus International, Inc.
General Hospital · 23d
Cleared Jun 23, 1988
BOUFFANT CAP
K882283 · FYF
A Plus International, Inc.
General & Plastic Surgery · 23d