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
116161–116184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1992
AMK FIXED STEM CEMENTED TIBIAL TRAY
K922620 · JWH
Depuy, Inc.
Orthopedic · 92d
Cleared Sep 02, 1992
KTP/532 & KTP/YAG
K913990 · GEX
Laserscope
General & Plastic Surgery · 363d
Cleared Sep 02, 1992
JANSEN-ANDERSON INSEMINATION SET
K914150 · MFD
Cook Ob/Gyn
Obstetrics & Gynecology · 352d
Cleared Sep 02, 1992
SALIVA-STIM
K914892 · EGD
Orion Diagnostica, Inc.
Dental · 307d
Cleared Sep 02, 1992
VISOR SUNGLASSES/LENS/NOVELTY VISOR
K915266 · HQY
Janlin Ent.
Ophthalmic · 287d
Cleared Sep 02, 1992
PHARMETRIX MEDIPUMP MODEL 524
K915407 · FRN
Pharmetrix, Inc.
General Hospital · 275d
Cleared Sep 02, 1992
MONI-TROL-L AND MONI-TROL-XL
K920291 · JJY
Medical Analysis Systems, Inc.
Chemistry · 224d
Cleared Sep 02, 1992
URO-TOTE LEG BAG
K921024 · KNX
Neotech Products, Inc.
Gastroenterology & Urology · 183d
Cleared Sep 02, 1992
SOLUTION ADMINISTRATION SET
K921391 · FPA
Douglas Medical Products Corp.
General Hospital · 163d
Cleared Sep 02, 1992
HOT SACK
K921395 · LGZ
C.F. Electronics, Inc.
General Hospital · 162d
Cleared Sep 02, 1992
SOLAZ
K921685 · HQY
Solarchromic, Inc.
Ophthalmic · 148d
Cleared Sep 02, 1992
COTUBE PTH IRMA
K921949 · CEW
Bio-Rad
Chemistry · 128d
Cleared Sep 02, 1992
SUCTION IRRIGATION CAUTERY PROBE
K922002 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 126d
Cleared Sep 02, 1992
LABOTECH AUTOMATED MICROTITER ANALYZER
K922081 · JJQ
Innovative Medical Systems, Inc.
Chemistry · 120d
Cleared Sep 02, 1992
AMERLITE PROLACTIN-30 ASSAY
K922170 · CFT
Eastman Kodak Company
Chemistry · 117d
Cleared Sep 02, 1992
TUBING SET W/ IRRIGATION & ASPIRATION VALVING
K922246 · GCJ
Everest Medical Corp.
General & Plastic Surgery · 112d
Cleared Sep 02, 1992
SPECTACLE FRAMES
K922258 · HQZ
British Optical Import Co.
Ophthalmic · 119d
Cleared Sep 02, 1992
ILLUMINATOR IV MINOR SURGERY LIGHT
K922279 · FSW
Medical Illumination, Inc.
General & Plastic Surgery · 110d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGG EIA
K922330 · LJB
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · LJN
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · LSE
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGM EIA
K922335 · LJB
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Sep 02, 1992
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
K922489 · FWP
Porex Technologies Corp.
General & Plastic Surgery · 98d
Cleared Sep 02, 1992
DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES
K922526 · GCJ
Davol, Inc.
General & Plastic Surgery · 97d