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
125881–125904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1990
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
K901243 · LJP
Cel Labs Pty, Ltd.
Microbiology · 67d
Cleared May 21, 1990
THE TONGUE BRUSH
K901408 · LCN
Garry Laboratories, Inc.
Dental · 56d
Cleared May 21, 1990
PATHO DX STREP D
K902038 · GTZ
Diagnostic Products Corp.
Immunology · 17d
Cleared May 18, 1990
CAV SAT OXIMETER MODEL 100
K892217 · DQA
Somanetics Corp.
Anesthesiology · 410d
Cleared May 18, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892305 · LYY
Hemipan Trading & Mfg. Co. (P) , Ltd.
General Hospital · 407d
Cleared May 18, 1990
PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.)
K893072 · LYZ
Innovative Medical Suppliers
General Hospital · 400d
Cleared May 18, 1990
FRANK INHALER THERMAL S
K895115 · CCQ
Buttner-Frank GmbH
Anesthesiology · 276d
Cleared May 18, 1990
DESERET MULTILUMEN SUBCLAVIAN CATHETER
K895735 · LYY
Deseret Medical, Inc.
General Hospital · 233d
Cleared May 18, 1990
SECHRIST VOLUME VENTILATOR MODEL 2200B
K896269 · CBK
Sechrist Industries, Inc.
Anesthesiology · 199d
Cleared May 18, 1990
LATEX PATIENT EXAMINATION GLOVES
K900119 · LYY
Cen Tex Industrial Co., Ltd.
General Hospital · 129d
Cleared May 18, 1990
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)
K900127 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 129d
Cleared May 18, 1990
IN-THE NEBULIZER
K900470 · CAF
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 107d
Cleared May 18, 1990
SYRINGE DISPOSAL SYSTEM
K900687 · FMF
National Syringe Disposal, Inc.
General Hospital · 94d
Cleared May 18, 1990
VISI-SORB ABSORBANT STICK
K900786 · HOZ
Visitec Co.
Ophthalmic · 87d
Cleared May 18, 1990
WHEELED STRETCHER
K900872 · FPO
Hospital Supply Co., Inc.
General Hospital · 81d
Cleared May 18, 1990
PEDIATRIC HOSPITAL BED
K900873 · FMS
Hospital Supply Co., Inc.
General Hospital · 81d
Cleared May 18, 1990
IN-LINE VIAL CONNECTION SITE
K900909 · FPA
Baxter Healthcare Corp
General Hospital · 80d
Cleared May 18, 1990
PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL
K900929 · HQX
Oculo Plastik, Inc.
Ophthalmic · 80d
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078 · BTO
L H M Ent., Inc.
Anesthesiology · 72d
Cleared May 18, 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079 · BTO
L H M Ent., Inc.
Anesthesiology · 72d
Cleared May 18, 1990
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K901119 · BSZ
Ohmeda Medical
Anesthesiology · 67d
Cleared May 18, 1990
LIFE AID RESUSCITATOR
K901218 · BTM
Clarendon Supplies , Ltd.
Anesthesiology · 65d
Cleared May 18, 1990
AMICON HEMOCONCENTRATOR SET
K901286 · KDI
Amicon, Inc.
Gastroenterology & Urology · 59d
Cleared May 18, 1990
HGP II TOTAL HIP FEMERAL STEM
K901364 · JDI
Zimmer, Inc.
Orthopedic · 56d