FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125713–125736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1990
PAPILLOTOME
K901434 · KWS
Telemed Systems, Inc.
Orthopedic · 74d
Cleared Jun 08, 1990
MESAMIV RECORDER
K901466 · BZQ
Madaus Medtec, Inc.
Anesthesiology · 72d
Cleared Jun 08, 1990
NIDEK RT-1200S (MARCO TRS-1200)
K901513 · HKO
Nidek, Inc.
Ophthalmic · 70d
Cleared Jun 08, 1990
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K901686 · HQC
Nidek, Inc.
Ophthalmic · 57d
Cleared Jun 08, 1990
KINAMED CEMENTED ATH-LONG STEM
K902073 · LZO
Kinamed, Inc.
Orthopedic · 32d
Cleared Jun 08, 1990
KINAMED CEMENTED CTH STEM
K902074 · LZO
Kinamed, Inc.
Orthopedic · 32d
Cleared Jun 08, 1990
TBD TENS REUSABLE ELECTRODE
K902195 · GXY
Empi
Neurology · 23d
Cleared Jun 08, 1990
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT
K902366 · FFT
Synectics-Dantec
Gastroenterology & Urology · 23d
Cleared Jun 07, 1990
BEHRING LASER NEPHELOMETER
K761234 · JZW
Behring Diagnostics, Inc.
Immunology
Cleared Jun 07, 1990
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
K891007 · KPI
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 465d
Cleared Jun 07, 1990
MINT SCENTED CONDOMS
K900679 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 115d
Cleared Jun 07, 1990
CHEMOPLUS GLOVE
K901411 · LYY
Biosafety Systems, Inc.
General Hospital · 73d
Cleared Jun 07, 1990
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
K902019 · HDF
Gynescope Corp.
Obstetrics & Gynecology · 35d
Cleared Jun 07, 1990
CROAK OVARIAN BIOPSY FORCEP
K902049 · HFB
Gynescope Corp.
Obstetrics & Gynecology · 31d
Cleared Jun 07, 1990
ULTRA.SPEC NON-STERILE LATEX EXAMINATION GLOVE
K902282 · LYY
Ncl Corp.
General Hospital · 16d
Cleared Jun 07, 1990
CARRINGTON WOUND DRESSING
K902345 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 13d
Cleared Jun 06, 1990
RUBBER CONTRACEPTIVE (CONDOM)
K896142 · HIS
Guangzhou No. 11 Rubber Factory
Obstetrics & Gynecology · 225d
Cleared Jun 06, 1990
SINOVENT MAXILLARY SINUS DRAINAGE SYSTEM
K896630 · KAM
Atos Medical AB
General & Plastic Surgery · 196d
Cleared Jun 06, 1990
RUBBER CONDOM (NON-COLORED)
K896987 · HIS
Hankook Latex Gongup Co., Ltd.
Obstetrics & Gynecology · 175d
Cleared Jun 06, 1990
PROMISE ABSORBENT PROTECTIVE PAD
K900421 · HHD
Scott Health Care
Obstetrics & Gynecology · 127d
Cleared Jun 06, 1990
WOUND TREATMENT KIT
K901109 · FRO
Orion Life Systems, Inc.
General & Plastic Surgery · 89d
Cleared Jun 06, 1990
HYPODERMIC SYRINGE LUER LOK
K901203 · FMF
Ware-Medics Glass Works, Inc.
General Hospital · 84d
Cleared Jun 06, 1990
RUBBER, DENTAL DAM (NON-STERILE)
K901236 · EIE
Naturub Sdn. Bhd.
Dental · 83d
Cleared Jun 06, 1990
BIPOLARD POLYPECTOMY SYSTEM (TM)
K901302 · GEI
Medical Devices, Inc.
General & Plastic Surgery · 78d