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
128305–128328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895123 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 13, 1989
BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))
K895251 · KPN
C.R. Bard, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 13, 1989
CARDS O.S. (TM) HCG-URINE
K895390 · JHI
Pacific Biotech, Inc.
Chemistry · 75d
Cleared Nov 13, 1989
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · JAA
Shimadzu Corp.
Radiology · 68d
Cleared Nov 13, 1989
MODIFIED SPANTRON FRAME FREEZE
K895546 · JAA
Spantron, Inc.
Radiology · 61d
Cleared Nov 13, 1989
MODIFIED HOMECLINIC PREGNANCY TEST
K895560 · LCX
Vanguard Biomedical Corp.
Chemistry · 68d
Cleared Nov 13, 1989
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
K895585 · JIS
Hichem Diagnostics
Chemistry · 59d
Cleared Nov 13, 1989
API UNISCEPT KB
K895796 · JWY
Analytical Products, Inc.
Microbiology · 46d
Cleared Nov 13, 1989
ABBOTT IMX IGE
K895914 · DGC
Abbott Laboratories
Immunology · 34d
Cleared Nov 13, 1989
RADKOR DXG-650R
K895969 · IZO
Radkor, Inc.
Radiology · 32d
Cleared Nov 13, 1989
ALANINE AMINOTRANSFERASE (ALT)
K896001 · CKA
American Monitor Corp.
Chemistry · 31d
Cleared Nov 13, 1989
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
K896321 · BSY
Superior Healthcare Group, Inc.
Anesthesiology · 12d
Cleared Nov 09, 1989
RAPIDEC STAPH
K891004 · LQL
Dms Products, Inc.
Microbiology · 254d
Cleared Nov 09, 1989
PROMONTORY STIMULATING ELECTRODE
K895081 · GXY
Cadwell Laboratories, Inc.
Neurology · 87d
Cleared Nov 09, 1989
CROSS CANCELLOUS BONE SCREW
K896044 · HWC
Buckman Co., Inc.
Orthopedic · 23d
Cleared Nov 09, 1989
FIBRINOGEN ASSAY KIT
K896052 · KQJ
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Nov 09, 1989
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
K896092 · GHD
Sigma Chemical Co.
Hematology · 21d
Cleared Nov 09, 1989
PARA TECH FOR TECHNICON H-1
K896154 · JCN
Streck Laboratories, Inc.
Hematology · 16d
Cleared Nov 08, 1989
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · CAC
Gish Biomedical, Inc.
Anesthesiology · 212d
Cleared Nov 08, 1989
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
K892856 · KRI
Acacia Laboratories, Inc.
Cardiovascular · 204d
Cleared Nov 08, 1989
LATEX EXAMINATION GLOVES
K893350 · LYY
Pan Africa Exports , Ltd.
General Hospital · 201d
Cleared Nov 08, 1989
QUANTAI UG REAGENT STRIP
K893661 · CGA
Quantai Biotronics, Inc.
Chemistry · 177d
Cleared Nov 08, 1989
DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
K894106 · FIP
Cd Medical, Inc.
Gastroenterology & Urology · 152d
Cleared Nov 08, 1989
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
K894715 · CGS
Catachem, Inc.
Chemistry · 106d