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
102601–102624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1995
BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP
K945841 · HFW
W G M Corp.
Obstetrics & Gynecology · 181d
Cleared May 30, 1995
SKALPI 3200
K946382 · IRO
Wiscco Development, Inc.
Physical Medicine · 167d
Cleared May 30, 1995
URETHRAL CATHETERIZATION TRAY
K950390 · FCM
Medcare Custom Packaging, Inc.
Gastroenterology & Urology · 118d
Cleared May 30, 1995
SALINE SOLUTINE, STERILE
K950560 · IGE
Busse Hospital Disposables, Inc.
Pathology · 111d
Cleared May 30, 1995
TOTAL SHOULDER PROSTHESIS
K950651 · KWS
Encore Orthopedics, Inc.
Orthopedic · 106d
Cleared May 30, 1995
PULMONEX DYNAMIC AIR THERAPY UNIT
K950756 · IKZ
Hill-Rom, Inc.
Physical Medicine · 102d
Cleared May 30, 1995
ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS
K950855 · DQO
Adam Spence Corp.
Cardiovascular · 92d
Cleared May 30, 1995
HIP FIXATION SYSTEM
K950866 · IYE
Medtec, Inc.
Radiology · 92d
Cleared May 30, 1995
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
K950929 · CAZ
Sherwood Medical Co.
Anesthesiology · 90d
Cleared May 30, 1995
STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER
K951141 · LMB
Star Technologies, Inc.
Radiology · 78d
Cleared May 30, 1995
DIGITAL RETINOSCOPIC PHOTOMETER
K951179 · HKO
Kudi Kalu, Inc.
Ophthalmic · 75d
Cleared May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
K951191 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d
Cleared May 30, 1995
FE-24X, FIBER ESOPHAGOSCOPE
K951197 · GCL
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d
Cleared May 30, 1995
FE-34TH, FIBER ESOPHAGOSCOPE
K951198 · GCL
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d
Cleared May 30, 1995
CONNECTING TUBE
K951745 · BSY
Vital Signs, Inc.
Anesthesiology · 50d
Cleared May 30, 1995
INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR...
K951896 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared May 30, 1995
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · DBA
Kent Laboratories, Inc.
Immunology · 33d
Cleared May 30, 1995
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · DAK
Kent Laboratories, Inc.
Immunology · 33d
Cleared May 30, 1995
ADVIEWER 2000
K952188 · IXC
Adp , Ltd.
Radiology · 21d
Cleared May 26, 1995
SPECTACLE SUN GLASSES
K940324 · HQY
Occhiali, International Eyewear
Ophthalmic · 487d
Cleared May 26, 1995
ECG FAX MODEM
K941282 · LOS
Hewlett-Packard Co.
Cardiovascular · 441d
Cleared May 26, 1995
GIP/MEDI-GLOBE PAPILLOTOME
K943629 · KNS
Medi-Globe Corp.
Gastroenterology & Urology · 304d
Cleared May 26, 1995
GIP/MEDI-GLOBE POLYPECTOMY SNARES
K943935 · FDI
Medi-Globe Corp.
Gastroenterology & Urology · 287d
Cleared May 26, 1995
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · JKA
Sherwood Medical Co.
Chemistry · 277d