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
134425–134448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1988
VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
K883201 · HBI
Vital Metrics, Inc.
General & Plastic Surgery · 60d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F
K883346 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 60d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323
K883548 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC PANEL #80322
K883549 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STAPHYLOCOCCUS MIC #80324
K883550 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328
K883552 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331
K883553 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329
K883554 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332
K883555 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
FEF(TM) END-TIDAL CO2 DETECTOR
K883821 · CCK
Fenem, Inc.
Anesthesiology · 18d
Cleared Sep 23, 1988
FLOWTRON AC200/2
K874688 · IRP
Huntleigh Technology, Inc.
Physical Medicine · 315d
Cleared Sep 23, 1988
AREA (DENTAL CHAIR)
K880474 · KLC
Alpine Dental Equipment Co.
Dental · 232d
Cleared Sep 23, 1988
SKEMA (DENTAL UNIT)
K880475 · KLC
Alpine Dental Equipment Co.
Dental · 232d
Cleared Sep 23, 1988
IVY COMMANDER, MODEL 600
K882167 · LDR
Ivy Medical, Inc.
General Hospital · 122d
Cleared Sep 23, 1988
DUAL-TEMP(TM) COOLING/WARMING UNIT
K882310 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 112d
Cleared Sep 23, 1988
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427 · DXY
Ela Medical, Inc.
Cardiovascular · 102d
Cleared Sep 23, 1988
COLTENE PRESIDENT JET REGULAR BODY
K882800 · ELW
Coltene, Inc.
Dental · 78d
Cleared Sep 23, 1988
CASF DRILL GUIDE DG 170
K882871 · LYQ
Terray Manufacturing, Inc.
Orthopedic · 74d
Cleared Sep 23, 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · FPA
Baxter Healthcare Corp
General Hospital · 29d
Cleared Sep 23, 1988
STERILE EMPTY GLASS VIALS
K883686 · LDH
Farris Laboratories, Inc.
General Hospital · 25d
Cleared Sep 22, 1988
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
K875072 · GZJ
Amana Medical Group
Neurology · 288d