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
121633–121656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1991
SUNGLASSES
K910415 · HQY
K.M Optical Co.
Ophthalmic · 91d
Cleared May 01, 1991
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432 · LYC
Lifecore Biomedical, Inc.
Dental · 90d
Cleared May 01, 1991
IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS
K910499 · LGC
Vitek Systems, Inc.
Microbiology · 85d
Cleared May 01, 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684 · CEC
Ciba Corning Diagnostics Corp.
Chemistry · 71d
Cleared May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
K910737 · CDP
Serono-Baker Diagnostics, Inc.
Chemistry · 69d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · DIF
Analytical Control Systems, Inc.
Chemistry · 56d
Cleared May 01, 1991
REAL TIME X-RAY IMAGING SYSTEM
K911082 · LMA
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared May 01, 1991
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
K911109 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 58d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
K911170 · JIY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
K911177 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
SCHNEIDER WALLSTENT(R)
K911292 · FGE
Pfizer Hospital Products Group, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 30, 1991
BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE
K903345 · FAD
C.R. Bard, Inc.
Gastroenterology & Urology · 279d
Cleared Apr 30, 1991
DR. DEDO'S FAMILY EAR EXAMINATION KIT
K904659 · ERA
Panex Corp.
Ear, Nose, Throat · 197d
Cleared Apr 30, 1991
HT4-SERIES HYSTEROSCOPES AND ACCESSORIES
K905392 · HIH
Frigitronics, Inc.
Obstetrics & Gynecology · 151d
Cleared Apr 30, 1991
MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
K905704 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 130d
Cleared Apr 30, 1991
AMYLASE
K910158 · JFJ
Pointe Scientific, Inc.,
Chemistry · 105d
Cleared Apr 30, 1991
ARGIPLUS
K910467 · EJS
Argen Precious Metals, Inc.
Dental · 85d
Cleared Apr 30, 1991
CIBA CORNING ACS TSH IMMUNOASSAY
K910981 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 54d