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
128569–128592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1989
GYROSCAN T5 MOBILE
K895869 · LNH
Philips Medical Systems, Inc.
Radiology · 71d
Cleared Dec 14, 1989
PROFIL CONDOM (RUBBER LATEX)
K895894 · HIS
Rfsu
Obstetrics & Gynecology · 70d
Cleared Dec 14, 1989
HYSTEROFLATOR 2001
K895907 · HIG
Cabot Medical Corp.
Obstetrics & Gynecology · 69d
Cleared Dec 14, 1989
STERILE DISPOSABLE INFRATIP
K895918 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 65d
Cleared Dec 14, 1989
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 57d
Cleared Dec 14, 1989
RADIATION PROTECTION APRON
K896289 · KPY
Infab Corp.
Radiology · 44d
Cleared Dec 14, 1989
KEY VASCULAR BOOTIES
K896472 · MAW
Key Surgical, Inc.
General & Plastic Surgery · 31d
Cleared Dec 14, 1989
JAW BLOCKER
K896745 · JXL
Plastic Engineered Products Co.
Neurology · 14d
Cleared Dec 13, 1989
VERIMED MYOEXORCISER III (MYO III)
K892649 · HCC
Verimed Holdings, Inc.
Neurology · 245d
Cleared Dec 13, 1989
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 177d
Cleared Dec 13, 1989
DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB.
K894356 · LDD
Phycon
Cardiovascular · 152d
Cleared Dec 13, 1989
TEST ONE
K894662 · IKK
Primed Products, Inc.
Physical Medicine · 142d
Cleared Dec 13, 1989
MT96000 PAPER CHART RECORDER
K894736 · DSF
Astro-Med, Inc.
Cardiovascular · 139d
Cleared Dec 13, 1989
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K894925 · EZN
Intec Medical, Inc.
Gastroenterology & Urology · 133d
Cleared Dec 13, 1989
GEL-TAC(R)
K895009 · LDD
Padeco, Inc.
Cardiovascular · 127d
Cleared Dec 13, 1989
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 117d
Cleared Dec 13, 1989
MODEL ELI-100/ST ELECTROCARDIOGRAPH
K895232 · LOS
Mortara Instrument, Inc.
Cardiovascular · 114d
Cleared Dec 13, 1989
LYME IGG ELISA TEST SYSTEM
K895292 · LSR
Zeus Scientific, Inc.
Microbiology · 110d
Cleared Dec 13, 1989
THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION
K895444 · INW
Mcvicar Enterprises, Ltd.
Physical Medicine · 99d
Cleared Dec 13, 1989
MODEL: IR205 ARTICULATED SURGICAL LASER
K895581 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 89d
Cleared Dec 13, 1989
VASCULAR CLAMP
K895691 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 83d
Cleared Dec 13, 1989
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
K895916 · DRF
Prucka Engineering, Inc.
Cardiovascular · 64d
Cleared Dec 13, 1989
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
K896112 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K896113 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d