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
112897–112920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1993
MARCO H AND TS-1 INSTRUMENT TABLES
K930447 · HRJ
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jul 06, 1993
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
K930449 · HME
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Jul 06, 1993
ROCHE CARDIOTROL-CK
K930889 · JJT
Roche Diagnostic Systems, Inc.
Chemistry · 134d
Cleared Jul 06, 1993
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
K931465 · JBD
Helena Laboratories
Hematology · 104d
Cleared Jul 06, 1993
LACTOCARD
K931901 · DEG
Touch Scientific, Inc.
Immunology · 78d
Cleared Jul 06, 1993
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
K932225 · MID
Immuno Concepts, Inc.
Immunology · 60d
Cleared Jul 02, 1993
SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM
K915258 · FIP
Aqua-Med Systems, Inc.
Gastroenterology & Urology · 591d
Cleared Jul 02, 1993
HARGIS SR2 SELF-RETRACTION SYSTEM
K921017 · GAD
Medin Corp.
General & Plastic Surgery · 486d
Cleared Jul 02, 1993
HARGIS RECTAL SELF RETRATION SYSTEM
K921019 · GAD
Medin Corp.
General & Plastic Surgery · 486d
Cleared Jul 02, 1993
HARGIS SELF RETRACTION SYSTEM
K921020 · GAD
Medin Corp.
General & Plastic Surgery · 486d
Cleared Jul 02, 1993
ELECTROSURGICAL UNIT
K921271 · GEI
E & M Engineering, Inc.
General & Plastic Surgery · 472d
Cleared Jul 02, 1993
VASOVASOSTOMY SET
K921546 · KOA
Cook Urological, Inc.
Gastroenterology & Urology · 457d
Cleared Jul 02, 1993
CATHETER INSERTION TRAY
K922179 · FMI
Medcare Custom Packaging, Inc.
General Hospital · 420d
Cleared Jul 02, 1993
MID-CANADA MEDICAL
K922839 · IMI
Mid-Canada Medical
Physical Medicine · 385d
Cleared Jul 02, 1993
TRANSFER SET
K923782 · LHI
Pacific Device, Inc.
General Hospital · 339d
Cleared Jul 02, 1993
WOUND DRESSING KIT
K923905 · MCY
Kit Pak, Inc.
General & Plastic Surgery · 332d
Cleared Jul 02, 1993
LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS
K924134 · GCS
Leisegang Medical, Inc.
Gastroenterology & Urology · 318d
Cleared Jul 02, 1993
IV START KIT
K924538 · LRS
Cml, Inc.
General & Plastic Surgery · 297d
Cleared Jul 02, 1993
INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
K924944 · EMX
Westmed Intl.
Ear, Nose, Throat · 275d
Cleared Jul 02, 1993
SHAVE PREP TRAYS (NON-STERILE)
K925214 · LRO
American Healthcare Supply Co., Inc.
General & Plastic Surgery · 259d
Cleared Jul 02, 1993
AP01 AND AP02
K925908 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 224d
Cleared Jul 02, 1993
BONE MARROW BIOPSY PROCEDURE TRAY
K930158 · GAA
Symbiosis Corp.
General & Plastic Surgery · 170d
Cleared Jul 02, 1993
INTERTRON 6000/6100
K930186 · IMI
Williams Healthcare Systems, LLC
Physical Medicine · 169d
Cleared Jul 02, 1993
CEPTI-SEAL I.V. PREP KIT
K930196 · LRS
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 169d