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
102649–102672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared May 25, 1995
CARDON PHYSICAL THERAPY TABLE MODEL: R27841
K950872 · INQ
Cardon Rehabilitation Products, Inc.
Physical Medicine · 86d
Cleared May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 84d
Cleared May 25, 1995
AUDIOTECH MODEL SPI
K950963 · ESD
Muskogee Regional Hearing Aid Lab
Ear, Nose, Throat · 84d
Cleared May 25, 1995
SILICONE FOLEY CATHETER
K951106 · EZL
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared May 25, 1995
KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
K951140 · HFW
Balagan Medical, Inc.
Obstetrics & Gynecology · 73d
Cleared May 25, 1995
LINK SADDLE PROTHESIS
K951355 · KWL
Turnkey Intergration USA, Inc.
Orthopedic · 78d
Cleared May 25, 1995
JAI
K951513 · LYY
Intl. Trade Management Co.
General Hospital · 52d
Cleared May 25, 1995
COMPOLGLASS COMPOGLASS SCA
K951836 · EBF
Ivoclar North America, Inc.
Dental · 35d
Cleared May 25, 1995
ULTRA SPHERICAL AMALGAM ALLOY
K951865 · EJJ
Goldsmith & Revere, Inc.
Dental · 34d
Cleared May 25, 1995
PROSYS LEG BAG
K951945 · FAQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 29d
Cleared May 25, 1995
SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD...
K952098 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 25, 1995
CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES
K952204 · GEI
Conmedcorp
General & Plastic Surgery · 15d
Cleared May 24, 1995
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
K926496 · GBX
Sil-Med Corp.
General & Plastic Surgery · 876d
Cleared May 24, 1995
TEMPORARY SCREENING LEAD/ CATHETER KIT
K934939 · MAJ
Medtronic Vascular
General Hospital · 583d
Cleared May 24, 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
K935877 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 531d
Cleared May 24, 1995
SINUSCOPE
K940317 · EOB
Stephen Chakoff, Inc.
Ear, Nose, Throat · 485d
Cleared May 24, 1995
DENTAL 911
K941066 · EMB
L.A.F. Industries, Inc.
Dental · 442d
Cleared May 24, 1995
ORTHODONTIC ELASTOMERIC LAGATURE MODULE
K943419 · ECI
Jon-Ko Products, Inc.
Dental · 313d
Cleared May 24, 1995
MINI S.F.T. (URINE PRESERVATIVE)
K943466 · LXG
Cambridge Diagnostic Products, Inc.
Chemistry · 343d
Cleared May 24, 1995
PRO'TECT
K943558 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d
Cleared May 24, 1995
REMOTE A'LERT
K943559 · KPN
Health Sense Intl., Inc.
Gastroenterology & Urology · 306d
Cleared May 24, 1995
RIONET HM-02
K943808 · ESD
Rockwin Corp.
Ear, Nose, Throat · 293d
Cleared May 24, 1995
BSM-8800A BEDSIDE MONITOR
K944422 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 281d