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
99601–99624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1995
CORDGUARD II
K954619 · KNA
Utah Medical Products, Inc.
Obstetrics & Gynecology · 77d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM N
K954655 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM P
K954656 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 21, 1995
CEDIA T UPTAKE ASSAY
K954807 · KHQ
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Dec 21, 1995
ECHONET
K954860 · LLZ
Heartlab, Inc.
Radiology · 59d
Cleared Dec 21, 1995
SIERRA BATTERY SEALED LEAD ACID BATTERY SYSTEM
K955095 · IZL
Sierra Battery, Inc.
Radiology · 44d
Cleared Dec 21, 1995
EASY BREATHING NASAL STRIPS
K955233 · LWF
Corbett Lair, Inc.
Ear, Nose, Throat · 37d
Cleared Dec 21, 1995
IMMULITE SHBG (MODIFICATION)
K955440 · CDZ
Diagnostic Products Corp.
Chemistry · 59d
Cleared Dec 21, 1995
TYMPANOSTOMY TUBE
K955447 · ETD
Trebay Medical Corp.
Ear, Nose, Throat · 22d
Cleared Dec 20, 1995
3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY
K943304 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 530d
Cleared Dec 20, 1995
3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY
K943307 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 530d
Cleared Dec 20, 1995
IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II
K946337 · EGJ
Skylark Device Co., Ltd.
Physical Medicine · 356d
Cleared Dec 20, 1995
CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K950919 · GKZ
Caltag Laboratories, Inc.
Hematology · 294d
Cleared Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · LGD
Bio-Rad Laboratories, Inc.
Microbiology · 264d
Cleared Dec 20, 1995
HM-SPIRO
K951718 · BZG
Hill-Med, Inc.
Anesthesiology · 251d
Cleared Dec 20, 1995
COURIER BALLOON DILATATION CATHETER
K953569 · LIT
Boston Scientific Corp
Cardiovascular · 142d
Cleared Dec 20, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K953608 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 140d
Cleared Dec 20, 1995
PROSYS BEDSIDE DRAINAGE BAG
K953767 · FAQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 131d
Cleared Dec 20, 1995
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
K954150 · BTM
Green Field Medical Sourcing, Inc.
Anesthesiology · 106d
Cleared Dec 20, 1995
BAGRIGHT RESUSCITATOR
K954296 · BTM
Medical Marketing Concepts
Anesthesiology · 97d
Cleared Dec 20, 1995
OLYMPIC INFANT THERMOMETER
K954434 · FLL
Olympic Medical Corp.
General Hospital · 86d
Cleared Dec 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
K954515 · GOM
Pyramid Biological Corp.
Microbiology · 83d
Cleared Dec 20, 1995
WAKO AUTOKIT APO B
K954657 · DFC
Wako Chemicals USA, Inc.
Immunology · 71d
Cleared Dec 20, 1995
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · JTO
Microbiologics, Inc.
Microbiology · 62d