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
128617–128640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1989
SPRING LATEX EXAMINATION GLOVES
K894213 · LYY
Brandywine Surgical, Inc.
General Hospital · 175d
Cleared Dec 11, 1989
LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.)
K895637 · LYY
Transcontinental Fertilizer Co.
General Hospital · 83d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (NON STERILE)
K895657 · LYY
Ka Hung Development , Ltd.
General Hospital · 82d
Cleared Dec 11, 1989
PAP SMEAR TRAY
K895675 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 82d
Cleared Dec 11, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · LLM
Immuno Concepts, Inc.
Microbiology · 77d
Cleared Dec 11, 1989
PRESSURE STEAM STERILIZERS
K895848 · FLE
Scientific Device Laboratory, Inc.
General Hospital · 69d
Cleared Dec 11, 1989
GLOVE N GEL
K896306 · LYY
Ems Medical, Inc.
General Hospital · 42d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
K896334 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
CLP GLYCOSYLATED HEMOGLOBIN CONTROL-NR
K896335 · LCP
Creative Laboratory Products, Inc.
Hematology · 38d
Cleared Dec 11, 1989
WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES
K896399 · LYY
Prime Horizon, Inc.
General Hospital · 34d
Cleared Dec 11, 1989
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · GJS
Medical Diagnostic Technologies, Inc.
Hematology · 20d
Cleared Dec 08, 1989
LORD L.F.R. TOTAL HIP SYSTEM
K884890 · JDI
Howmedica Corp.
Orthopedic · 381d
Cleared Dec 08, 1989
RECTUM-COLON MOTILITY MONITOR
K884920 · FAP
Multi-Spectrum Consulting, Inc.
Gastroenterology & Urology · 375d
Cleared Dec 08, 1989
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
K894068 · HSX
Kirschner Medical Corp.
Orthopedic · 183d
Cleared Dec 08, 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K894939 · FPD
North American Sterilization &...
Gastroenterology & Urology · 127d
Cleared Dec 08, 1989
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · GZJ
Medical Devices, Inc.
Neurology · 88d
Cleared Dec 08, 1989
MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT
K895502 · EPP
Microbio-Medics, Inc.
Ear, Nose, Throat · 87d
Cleared Dec 08, 1989
CALASEPT PASTE
K895508 · EJK
Js Dental Mfg., Inc.
Dental · 88d
Cleared Dec 08, 1989
PHASE II ORTHODONTIC ADHESIVE
K895523 · DYH
Reliance Orthodontic Products, Inc.
Dental · 87d
Cleared Dec 08, 1989
B-D PEND NEEDLE
K895630 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 80d
Cleared Dec 08, 1989
HEMOSTAT/STIMULATOR PROBE
K895676 · ETN
Rln Systems, Inc.
Ear, Nose, Throat · 79d
Cleared Dec 08, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · LLM
Immuno Concepts, Inc.
Microbiology · 74d
Cleared Dec 08, 1989
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 08, 1989
1.2 MICRON FILTER WITH IV SET
K896292 · FPB
Kendall Mcgaw Laboratories, Inc.
General Hospital · 38d