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
131521–131544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1989
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · DYB
Argon Medical Corp.
Cardiovascular · 80d
Cleared May 19, 1989
MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
K891230 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 73d
Cleared May 19, 1989
ARGELITE 58P (DENTAL ALLOY)
K891320 · EJT
Argen Precious Metals, Inc.
Dental · 67d
Cleared May 19, 1989
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
K891463 · EBF
Confi-Dental Products Co.
Dental · 65d
Cleared May 19, 1989
HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS
K892211 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 46d
Cleared May 19, 1989
REXTON RX12PP, RX20PP & RX34PP IN-THE-EAR HEAR AID
K892333 · ESD
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared May 19, 1989
BEHIND-THE-EAR HEARING AID MODEL 48 PP PC
K892336 · ESD
Qualitone
Ear, Nose, Throat · 44d
Cleared May 19, 1989
KENDALL CURITY FEEDING TUBES
K892431 · FPD
The Kendal Co.
Gastroenterology & Urology · 39d
Cleared May 19, 1989
ARGEDENT Y-86 DENTAL ALLOY
K892708 · EJT
Argen Precious Metals, Inc.
Dental · 35d
Cleared May 19, 1989
ARGELITE 75+6
K892812 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 19, 1989
ARGELITE 60
K892813 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 19, 1989
ARGEDENT 45SF
K892815 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 19, 1989
ARGEDENT 38
K892816 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared May 19, 1989
ARGELITE 80SF DENTAL ALLOY
K892908 · EJT
Argen Precious Metals, Inc.
Dental · 29d
Cleared May 19, 1989
ARGELITE 54
K893008 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 19, 1989
ARGELITE SR+
K893009 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 19, 1989
ARGIPAL
K893011 · EJT
Argen Precious Metals, Inc.
Dental · 25d
Cleared May 18, 1989
MODIFIED THER-A-PULSE UNIT
K884396 · IPF
Westec Corp.
Physical Medicine · 211d
Cleared May 18, 1989
SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM
K884732 · DZE
Bio-Interfaces, Inc.
Dental · 189d
Cleared May 18, 1989
SGARLATO LESSER TOE IMPLANT
K884739 · KWH
Sgarlato Laboratories, Inc.
Orthopedic · 185d
Cleared May 18, 1989
MEM-7102
K890274 · GWF
Nihon Kohden America, Inc.
Neurology · 120d
Cleared May 18, 1989
INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)
K891176 · FPA
Multi-Med, Inc.
General Hospital · 73d
Cleared May 18, 1989
DENTIN PRIMER
K891455 · KLE
Dentsply Intl.
Dental · 64d
Cleared May 18, 1989
RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4
K891464 · DYH
Confi-Dental Products Co.
Dental · 64d