FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
130921–130944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1989
MULTI PULSE POWER UNIT GENERATOR
K892943 · IZO
GE Medical Systems
Radiology · 31d
Cleared May 19, 1989
FORTEC MI-150 DIGITAL BLOOD PRESSURE METER
K884405 · DXN
Nam Tai Electronic & Electrical...
Cardiovascular · 211d
Cleared May 19, 1989
THE COACH
K884804 · DRT
Promark, Inc.
Cardiovascular · 183d
Cleared May 19, 1989
E-Z-FLOW ANGIOGRAPHY CATHETERS
K890206 · DQO
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
HIGH PRESSURE CONNECTING SETS
K890208 · DXT
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
DISPOSABLE ANGIOGRAPHY NEEDLES
K890209 · DRC
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared May 19, 1989
PERSONAL ALERT ASSIST DEVICE
K890445 · LXI
Silent Call Corp.
Orthopedic · 112d
Cleared May 19, 1989
INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA
K890525 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 106d
Cleared May 19, 1989
KENDALL SCD THERAPEUTIC SYSTEM
K890938 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 84d
Cleared May 19, 1989
MODIFIED EXTERNAL PAD
K891000 · DWS
Instromedix, Inc.
Cardiovascular · 81d
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