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
128593–128616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
K896114 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
K896115 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
RED DOT CARDIAC SENSOR SYSTEM
K896155 · DRX
3M Company
Cardiovascular · 50d
Cleared Dec 13, 1989
CARDS O.S.(TM) STREP A
K896221 · GTZ
Pacific Biotech, Inc.
Microbiology · 44d
Cleared Dec 13, 1989
MINIMON 7133B PATIENT MONITOR
K896386 · DPS
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Dec 13, 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 30d
Cleared Dec 13, 1989
SPENCO BREAST FORMS
K896533 · KCZ
Spenco Medical Corp.
General & Plastic Surgery · 29d
Cleared Dec 13, 1989
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · DTC
Medtronic Vascular
Cardiovascular · 21d
Cleared Dec 12, 1989
CLOSED CHEST SUPPORT CIRCUIT
K893207 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 230d
Cleared Dec 12, 1989
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
K894355 · LDD
Phycon
Cardiovascular · 151d
Cleared Dec 12, 1989
ZYMED MODEL 1610
K895208 · DSI
Agilent Technologies
Cardiovascular · 117d
Cleared Dec 12, 1989
CALCIUM AND PH ELECTROLYTE ANALYZER
K895397 · JFP
Ionetics, Inc.
Chemistry · 102d
Cleared Dec 12, 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · DTZ
3M Company
Cardiovascular · 84d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · LDD
Marquette Electronics, Inc.
Cardiovascular · 83d
Cleared Dec 12, 1989
CALCIUM, CATALOGUE NUMBER140-20
K895873 · CJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Dec 12, 1989
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · JGS
Medica Corp.
Chemistry · 62d
Cleared Dec 12, 1989
CHOLESTEROL, UNIVERSAL ET
K896073 · CHH
Enzyme Technology, Inc.
Chemistry · 54d
Cleared Dec 12, 1989
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · CHP
Amersham Corp.
Chemistry · 42d
Cleared Dec 12, 1989
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329 · KLI
Photec Diagnostics, Inc.
Chemistry · 40d
Cleared Dec 12, 1989
KONTRON KOLORMON 7250 PATIENT MONITOR
K896417 · DPS
Kontron Instruments, Inc.
Cardiovascular · 34d
Cleared Dec 12, 1989
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · CGR
Microgenics Corp.
Chemistry · 33d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892091 · LYY
Rising Crown Industries , Ltd.
General Hospital · 252d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892636 · LYY
P.T. Latexindo Parama
General Hospital · 245d
Cleared Dec 11, 1989
PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY
K893513 · LYY
Pioneer Sundries Products , Ltd.
General Hospital · 220d