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
106513–106536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1994
PHILIPS THORAVISION
K931071 · KPR
Philips Medical Systems, Inc.
Radiology · 562d
Cleared Sep 15, 1994
IOLAB LACRIMAL DUCT CATHETER
K935233 · OKS
Chiron Vision Corp.
Ophthalmic · 318d
Cleared Sep 14, 1994
SURGIMAT
K926259 · HET
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 635d
Cleared Sep 14, 1994
LATEX PROPHYLACTIC RUBBER CONTRACEPTIVE
K931077 · HIS
J.K. Chemicals, Ltd.
Obstetrics & Gynecology · 560d
Cleared Sep 14, 1994
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 499d
Cleared Sep 14, 1994
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 469d
Cleared Sep 14, 1994
SWABZYME OXIDASE
K934130 · JTO
E-Y Laboratories, Inc.
Microbiology · 394d
Cleared Sep 14, 1994
SUNGLASSES
K940421 · HQY
Double Hero Corp.
Ophthalmic · 229d
Cleared Sep 14, 1994
MONOJECT LUER ADAPTER
K940961 · FMI
Sherwood Medical Co.
General Hospital · 196d
Cleared Sep 14, 1994
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
K941807 · CHG
Intersect Systems, Inc.
Chemistry · 155d
Cleared Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · GGN
Helena Laboratories
Hematology · 152d
Cleared Sep 14, 1994
PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY
K942009 · LCP
Primus Corp.
Hematology · 142d
Cleared Sep 14, 1994
NIDA-5/RT, DRUG OF ABUSE CONTROLS
K942041 · DIF
Meditech
Toxicology · 139d
Cleared Sep 14, 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · DIF
Medical Diagnostic Technologies, Inc.
Toxicology · 128d
Cleared Sep 14, 1994
IV START KITS
K943047 · KMK
Sterile Concepts, Inc.
General Hospital · 79d
Cleared Sep 14, 1994
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K943290 · JJY
Medi-Tech, Inc.
Chemistry · 68d
Cleared Sep 14, 1994
ILO MADE IN ITALY
K943296 · HQY
Ilo Industria Lombarda Ottica Srl
Ophthalmic · 68d
Cleared Sep 14, 1994
OPERA SYSTEM
K943376 · JJC
Miles, Inc.
Chemistry · 63d
Cleared Sep 14, 1994
SPECTACLE FRAME
K943561 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 54d
Cleared Sep 14, 1994
SUNGLASSES
K943562 · HQY
Australian Optical Co., Inc.
Ophthalmic · 54d
Cleared Sep 14, 1994
SUNGLASS CLIP
K943640 · HQY
Australian Optical Co., Inc.
Ophthalmic · 49d
Cleared Sep 14, 1994
SPECTACLE FRAME
K943641 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 49d
Cleared Sep 14, 1994
TROCARS,CANNULAE,SHEATHS,OBTURATORS
K943697 · ODB
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 47d
Cleared Sep 14, 1994
LIPASE CALIBRATOR
K943704 · JIT
The DU Pont Co.
Chemistry · 44d