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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
99649–99672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1995
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
K951600 · FDI
Mill-Rose Laboratory
Gastroenterology & Urology · 255d
Cleared Dec 18, 1995
PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER
K952073 · FLL
Intelligent Product Limited Co.
General Hospital · 230d
Cleared Dec 18, 1995
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
K952287 · MID
Reaads Medical Products, Inc.
Immunology · 216d
Cleared Dec 18, 1995
SERIM PYLORITEK TEST KIT
K953632 · LYR
Serim Research Corp.
Microbiology · 151d
Cleared Dec 18, 1995
WAKO AUTOKIT CH50
K954145 · DAE
Wako Chemicals USA, Inc.
Immunology · 104d
Cleared Dec 18, 1995
PS MEDICAL IPI VASCULAR ACCESS CATHETER
K954409 · LJS
Pudenz-Schulte Medical Research Corp.
General Hospital · 89d
Cleared Dec 18, 1995
ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE
K954439 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 84d
Cleared Dec 18, 1995
C-REACTIVE PROTEIN LATEX KIT
K954447 · DCK
Randox Laboratories, Ltd.
Immunology · 84d
Cleared Dec 18, 1995
ILT SURGICAL LASER
K954460 · GEX
Ion Laser Technology
General & Plastic Surgery · 84d
Cleared Dec 18, 1995
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE...
K954566 · DHB
Diagnostic Products Corp.
Immunology · 77d
Cleared Dec 18, 1995
ECTRA II LIGAMENT RELEASE SYSTEM
K954627 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 73d
Cleared Dec 18, 1995
NEO-MED DLS-1100
K954931 · GEX
Neo-Laboratories, LLC
General & Plastic Surgery · 54d
Cleared Dec 18, 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933 · LDP
Johnson & Johnson Clinical...
Toxicology · 52d
Cleared Dec 18, 1995
ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES
K954965 · GEI
Zomed Intl.
General & Plastic Surgery · 49d
Cleared Dec 18, 1995
VL2600 HANDSWITCHING PENCIL WITH HOLSTER
K955109 · GEI
Valleylab, Inc.
General & Plastic Surgery · 40d
Cleared Dec 18, 1995
NEUROVIEW COAXIAL BIPOLAR ELECTRODE
K955467 · GEI
Neuro Navigational Corp.
General & Plastic Surgery · 18d
Cleared Dec 18, 1995
INCL ENDOSCOPE
K955471 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 69d
Cleared Dec 15, 1995
AWESMOSIS
K945066 · FIP
Applied Water Engineering, Inc.
Gastroenterology & Urology · 427d
Cleared Dec 15, 1995
SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
K950042 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 344d
Cleared Dec 15, 1995
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · JOL
Sherwood Medical Co.
General Hospital · 331d
Cleared Dec 15, 1995
TEVES ECM PLUS THERMOCOUPLE
K951768 · BTR
Advanced Medical Concepts, Inc.
Anesthesiology · 242d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 234d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Dec 15, 1995
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
K952154 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 221d