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
105097–105120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1994
SHAVE PREP KIT
K945481 · LRO
Harding Industries, Inc.
General & Plastic Surgery · 45d
Cleared Dec 23, 1994
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K945527 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 23, 1994
WIDEX MODEL LOGO - L9
K945703 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 51d
Cleared Dec 23, 1994
IN-THE-EAR HEARING AID
K945710 · ESD
Truetone Hearing Systems, Inc.
Ear, Nose, Throat · 32d
Cleared Dec 22, 1994
PLAZLYTE(TM)
K905119 · FLF
Abtox, Inc.
General Hospital · 1499d
Cleared Dec 22, 1994
ABTOX PLAZLYTE PROCESS MONITOR
K923442 · FLF
Abtox, Inc.
General Hospital · 892d
Cleared Dec 22, 1994
ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR
K923739 · FRC
Abtox, Inc.
General Hospital · 878d
Cleared Dec 22, 1994
HEMOLAB
K931992 · GKP
Biomerieux Vitek, Inc.
Hematology · 608d
Cleared Dec 22, 1994
SONICAID MODEL P110 FETAL HEAR DETECTOR
K933816 · HEL
Oxford Instruments, Plc.
Obstetrics & Gynecology · 505d
Cleared Dec 22, 1994
BIOMERIEUX HEMOLAB AT III
K934156 · JBQ
Biomerieux Vitek, Inc.
Microbiology · 482d
Cleared Dec 22, 1994
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · GGP
Biomerieux Vitek, Inc.
Hematology · 479d
Cleared Dec 22, 1994
360 SLX ADVISORY DEFIBRILLATOR
K935922 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 374d
Cleared Dec 22, 1994
CROSSTEX SELF-SEALING STERILIZATION POUCH
K941327 · KCT
Cross Country Paper Products Corp.
General Hospital · 279d
Cleared Dec 22, 1994
AGEE-WRISTJACK PRE-DRILL KIT
K942906 · HTW
Hand Biomechanics Lab, Inc.
Orthopedic · 184d
Cleared Dec 22, 1994
AUTOSTAT II ANTI-THYROGLOBULIN
K943625 · DDC
Cogent Diagnotics , Ltd.
Immunology · 149d
Cleared Dec 22, 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · LNH
GE Medical Systems
Radiology · 121d
Cleared Dec 22, 1994
VARELISA RNP-SM ANTIBODIES
K944167 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA LA (SS-B) ANTIBODIES
K944168 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RO (SS-A) ANTIBODIES
K944169 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SM ANTIBODIES
K944170 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA CENTROMERE ANTIBODIES
K944171 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SCL-70 ANTIBODIES
K944172 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA JO-1 ANTIBODIES
K944173 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
JAMES LECKEY PRONE STANDER
K944307 · INW
James Leckey Design
Physical Medicine · 111d