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
131161–131184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · DHB
Quidel Corp.
Immunology · 27d
Cleared May 04, 1989
S-100 ALLEN-BROWN SHUNT
K892663 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 04, 1989
SAF-T-SHUNT, S-300 SERIES
K892666 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 04, 1989
SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313
K892667 · FKN
Akcess Medical Products, Inc.
Gastroenterology & Urology · 21d
Cleared May 03, 1989
ACROMED ILIAC SCREW
K884161 · KWP
Buckman Co., Inc.
Orthopedic · 211d
Cleared May 03, 1989
TOTAL CHOLESTEROL REAGENT
K890334 · CHH
Alpkem Corp.
Chemistry · 100d
Cleared May 03, 1989
LABSONICS MAMM-O-MATE MODEL NO. 918084-1
K890519 · IYO
Laboratory Equipment Corp.
Radiology · 90d
Cleared May 03, 1989
MAMMOMAT C
K890784 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 03, 1989
POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
K890792 · CEM
Ionetics, Inc.
Chemistry · 75d
Cleared May 03, 1989
GENERAL ELECTRIC AMX 110
K891143 · IZL
Pro-Tronics, Inc.
Radiology · 61d
Cleared May 03, 1989
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · DLB
Diagnostic Products Corp.
Toxicology · 58d
Cleared May 03, 1989
IQ CALCIUM
K891217 · CIC
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared May 02, 1989
OROSPHERE HCDP
K890681 · EJJ
Jeneric/Pentron, Inc.
Dental · 82d
Cleared May 02, 1989
SIEMENS SIRECUST 730 PATIENT MONITOR
K890791 · DPS
Siemens Medical Electronics
Cardiovascular · 74d
Cleared May 02, 1989
QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
K890998 · IYN
Quantum Medical Systems, Inc.
Radiology · 88d
Cleared May 02, 1989
IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
K891472 · LZV
Implant Technology, Inc.
Orthopedic · 48d
Cleared May 02, 1989
FILAFLEX ORTHODONTIC WIRE
K891599 · EJF
American Orthodontics
Dental · 43d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891976 · LYY
Ever Surplus (Usa), Inc.
General Hospital · 34d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891977 · LYY
Grandclass, Ltd.
General Hospital · 34d
Cleared May 02, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891978 · LYY
Latex Supply Products (Hp), Inc.
General Hospital · 34d
Cleared May 02, 1989
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · EKJ
Zinnanti Surgical Instruments, Inc.
Dental · 28d
Cleared May 01, 1989
BURNEY GALLBLADDER CATHETER KIT
K880343 · FGE
Mallinckrodt Critical Care
Gastroenterology & Urology · 461d
Cleared May 01, 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · DRX
S & W Medico Teknik
Cardiovascular · 153d
Cleared May 01, 1989
HEMATOME SYSTEM
K885066 · GET
Surgical Dynamics, Inc.
General & Plastic Surgery · 146d