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
126097–126120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1990
RESPONSE EXTERNAL PENILE RIGIDITY DEVICE
K900559 · LKY
Smith-Collins Pharmaceutical, Inc.
Gastroenterology & Urology · 84d
Cleared May 02, 1990
LYME IGM MICROASSAY
K900572 · LSR
Diamedix Corp.
Microbiology · 84d
Cleared May 02, 1990
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
K900735 · FMZ
Preemicare Corp.
General Hospital · 75d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796 · LFZ
Gull Laboratories, Inc.
Microbiology · 71d
Cleared May 02, 1990
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · CHI
American Research Products Co.
Chemistry · 70d
Cleared May 02, 1990
MAGNET RETRIEVAL CATHETER
K900852 · KNT
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared May 02, 1990
MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
K900892 · KPS
Siemens Gammasonics, Inc.
Radiology · 64d
Cleared May 02, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN
K901270 · DIF
Bio-Rad
Toxicology · 44d
Cleared May 02, 1990
EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
K901297 · JDI
Exactech, Inc.
Orthopedic · 43d
Cleared May 02, 1990
THROMBOPLASTIN.C PLUS
K901325 · GJS
Baxter Healthcare Corp
Hematology · 42d
Cleared May 02, 1990
WEINSTEIN STYLE INSTRUMENT HOLDER
K901486 · LDQ
David Ayres Medical Co.
General & Plastic Surgery · 34d
Cleared May 02, 1990
GDC 3084 CASTING ALLOY
K901532 · EJT
Deringer-Ney, Inc.
Dental · 30d
Cleared May 02, 1990
GDC 588 CASTING ALLOY
K901533 · EJT
The J.M. Co.
Dental · 30d
Cleared May 02, 1990
REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD
K901575 · GXY
Pioneering Technologies, Inc.
Neurology · 29d
Cleared May 02, 1990
NOVA LITE(TM) ANA KSL
K901596 · DHN
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 02, 1990
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K901674 · KHO
Tosoh Corp.
Chemistry · 22d
Cleared May 02, 1990
LATEX PATIENT EXAMINATION GLOVES
K901750 · LYY
Haikou Latex Factory
General Hospital · 15d
Cleared May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · LEH
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared May 02, 1990
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
K901807 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 12d
Cleared May 01, 1990
DILECTRON URINARY CONDUCTIVITY PROBE
K891681 · JRE
Gyrus Medical , Ltd.
Chemistry · 405d
Cleared May 01, 1990
ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
K900187 · FPA
Advance Medical Designs, Inc.
Radiology · 105d
Cleared May 01, 1990
ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
K900188 · FPA
Advance Medical Designs, Inc.
Radiology · 105d
Cleared May 01, 1990
ATS Y ADAPTER CODE #2452
K900299 · CAC
Artium Medical Corp.
Anesthesiology · 99d
Cleared May 01, 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
K900349 · BTM
Puritan Bennett Corp.
Anesthesiology · 97d