FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124513–124536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1990
VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL)
K904642 · LYZ
Predex Co. , Ltd.
General Hospital · 8d
Cleared Oct 17, 1990
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K903206 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 89d
Cleared Oct 17, 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 75d
Cleared Oct 17, 1990
ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N
K903598 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N
K903599 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N
K903600 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
KERATOME
K903912 · HNO
Micro Precision Instrument Co.
Ophthalmic · 54d
Cleared Oct 17, 1990
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077 · LJT
Med Institute, Inc.
General Hospital · 42d
Cleared Oct 17, 1990
PCA (R) TIBIAL BONE WEDGES
K904170 · JWH
Howmedica Corp.
Orthopedic · 36d
Cleared Oct 17, 1990
INSET PATELLAR COMPONENT
K904300 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 17, 1990
FOCUS COBALT CHROMIUM TOTAL HIP
K904351 · JDI
Depuy, Inc.
Orthopedic · 23d
Cleared Oct 17, 1990
SAFE-T-STIK
K904382 · FMF
Xikon Technology
General Hospital · 21d
Cleared Oct 17, 1990
PATIENT EXAMINATION GLOVES
K904443 · LYY
Pisak Enterprise Co., Ltd.
General Hospital · 19d
Cleared Oct 17, 1990
SONY CINE VIDEO SYSTEM SME-3500
K904447 · IZI
Sony Medical Electronics Co.
Radiology · 19d
Cleared Oct 17, 1990
VOLUMETRIC INFUSION PUMP
K904518 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 14d
Cleared Oct 16, 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · LIT
Boston Scientific Corp
Cardiovascular · 299d
Cleared Oct 16, 1990
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K900607 · DSI
Cardiodata Corp.
Cardiovascular · 250d
Cleared Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
K902143 · DWP
Baxter Healthcare Corp
Cardiovascular · 154d
Cleared Oct 16, 1990
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · LDF
Medtronic Vascular
Cardiovascular · 144d
Cleared Oct 16, 1990
LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE
K902518 · DTM
Pall Biomedical Products Co.
Cardiovascular · 132d
Cleared Oct 16, 1990
DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL
K902932 · DYB
Datascope Corp.
Cardiovascular · 105d
Cleared Oct 16, 1990
TOXO IGM ELISA TEST
K903324 · LGD
Gull Laboratories, Inc.
Microbiology · 83d
Cleared Oct 16, 1990
CHLAMYDIA ACCU-CULSHURE TM
K903405 · LIO
Medical Laboratory Automation...
Microbiology · 77d
Cleared Oct 16, 1990
VIRAL ACCU-CULSHURE TM
K903406 · LIO
Medical Laboratory Automation...
Microbiology · 77d