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
95185–95208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 1996
FILM SCANNER 300
K960839 · LMA
Cannon U.S.A., Inc.
Radiology · 296d
Cleared Dec 18, 1996
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049 · DCK
Polymedco, Inc.
Immunology · 204d
Cleared Dec 18, 1996
CAT SCOOTER WITH DS60 VONYTOLLRT
K962583 · INI
Invacare Respiratory Corp.
Physical Medicine · 170d
Cleared Dec 18, 1996
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
K962864 · KRZ
Alko Diagnostic Corp.
Hematology · 148d
Cleared Dec 18, 1996
REPLIDERM WOUND DRESSING
K963228 · KGN
Orphan Medical, Inc.
General & Plastic Surgery · 121d
Cleared Dec 18, 1996
STREPTOCOCCUS MIC PANEL
K963641 · JWY
Dade Microscan, Inc.
Microbiology · 97d
Cleared Dec 18, 1996
TOMTEC ECHO-SCAN
K963807 · IYO
Tomtec Imaging Systems, Inc.
Radiology · 86d
Cleared Dec 18, 1996
ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
K963826 · GEH
Endocare, Inc.
General & Plastic Surgery · 84d
Cleared Dec 18, 1996
QLVA PLUS
K963859 · LLZ
Sanders Data Systems, LLC
Radiology · 83d
Cleared Dec 18, 1996
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
K963861 · LMD
Dejarnette Research Systems
Radiology · 85d
Cleared Dec 18, 1996
C-ARM TABLE IVS-100
K963888 · JAA
Shimadzu Medical Systems
Radiology · 83d
Cleared Dec 18, 1996
MOBILE CT PROSPEED FAMILY
K963896 · JAK
GE Medical Systems
Radiology · 82d
Cleared Dec 18, 1996
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K963939 · CIG
Synermed, Inc.
Chemistry · 78d
Cleared Dec 18, 1996
IMIG-MRI
K963953 · LNH
Imig-Mri Systems, LLC
Radiology · 77d
Cleared Dec 18, 1996
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
K964072 · GAN
Ethicon, Inc.
General & Plastic Surgery · 68d
Cleared Dec 18, 1996
PHILIPS COMPUTED RADIOGRAPHY
K964124 · LLZ
Philips Medical Systems, Inc.
Radiology · 64d
Cleared Dec 18, 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · JWY
Ab Biodisk
Microbiology · 77d
Cleared Dec 18, 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · LBZ
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Dec 18, 1996
LINX NETWORKING SYSTEM
K964250 · LMD
Sterling Diagnostic Imaging, Inc.
Radiology · 55d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · GGP
Universal Reagents, Inc.
Hematology · 54d
Cleared Dec 18, 1996
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964442 · LEG
Bayer Corp.
Chemistry · 42d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · GGP
Universal Reagents, Inc.
Hematology · 41d
Cleared Dec 18, 1996
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4...
K964721 · KLI
Johnson & Johnson Clinical...
Chemistry · 23d
Cleared Dec 17, 1996
HYDRO-SELECT GUIDEWIRE
K954642 · DQX
Microvena Corp.
Cardiovascular · 434d