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
128521–128544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1989
PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
K893845 · BZC
Medical Associated Services, Inc.
Anesthesiology · 155d
Cleared Oct 27, 1989
SURGICAL GLOVES
K894010 · KGO
Green Cross Medical Supplies Corp.
General Hospital · 147d
Cleared Oct 27, 1989
INTOPO
K894206 · FMF
Acacia, Inc.
General Hospital · 130d
Cleared Oct 27, 1989
K.E.E. OXYGEN CONCENTRATOR
K894384 · CAW
Kee Medical Services, Inc.
Anesthesiology · 102d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT
K894493 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 100d
Cleared Oct 27, 1989
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS
K894742 · ITY
Inmark Corp.
Radiology · 102d
Cleared Oct 27, 1989
CRYSTALLINE C2 AND CRYSTALLINE L3
K894890 · EBF
Confi-Dental Products Co.
Dental · 87d
Cleared Oct 27, 1989
HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM
K894892 · DSB
Koven and Assoc., Inc.
Cardiovascular · 87d
Cleared Oct 27, 1989
LATEX PATIENT EXAMINATION GLOVES
K894908 · LYY
Shanghai Shen Hua Rubber and Plastics...
General Hospital · 87d
Cleared Oct 27, 1989
SOPHYCAMERA DSX RECTANGULAR
K894931 · IYX
Sopha Medical Systems, Inc.
Radiology · 86d
Cleared Oct 27, 1989
APERTURE
K895084 · IZS
Custom Medical Products, Ltd.
Radiology · 74d
Cleared Oct 27, 1989
MODEL 2031 TMJ SURFACE COIL
K895131 · LNH
Medical Advances, Inc.
Radiology · 71d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT II
K895152 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 78d
Cleared Oct 27, 1989
FORCE II
K895163 · DYH
American Orthodontics
Dental · 66d
Cleared Oct 27, 1989
FIRST MEDIC MODEL 610P
K895185 · LDD
First Medical Devices Corp.
Cardiovascular · 77d
Cleared Oct 27, 1989
FILMFAX
K895209 · LMD
Discovery Systems, Inc.
Radiology · 71d
Cleared Oct 27, 1989
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895231 · CAF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 66d
Cleared Oct 27, 1989
RESPIRONICS INFANT BAGEASY
K895351 · BTM
Respironics, Inc.
Anesthesiology · 56d
Cleared Oct 27, 1989
SHILEY ELBOW 15MM SWIVEL CONNECTOR
K895388 · BZA
Shiley, Inc.
Anesthesiology · 58d
Cleared Oct 27, 1989
BUN (KINETIC)
K895666 · CDQ
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Oct 27, 1989
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K895747 · CAP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 31d
Cleared Oct 27, 1989
ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400
K895786 · GEX
Luxar Corp.
General & Plastic Surgery · 32d
Cleared Oct 27, 1989
DIRD INGANT O2 (BIO 2 HOOD)
K895866 · BYL
Bird Products Corp.
Anesthesiology · 23d
Cleared Oct 27, 1989
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
K895995 · LJM
Lipogen, Inc.
Immunology · 14d