FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92377–92400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1997
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K971808 · CAF
Monarch Medical
Anesthesiology · 134d
Cleared Sep 26, 1997
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT...
K971979 · HIB
Playtex Products, Inc.
Obstetrics & Gynecology · 120d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Sep 26, 1997
ACS VIKING GUIDING CATHETER
K972484 · DQY
Guidant Corp.
Cardiovascular · 86d
Cleared Sep 26, 1997
EMG RETRAINER
K972487 · HCC
Chattanooga Group, Inc.
Neurology · 86d
Cleared Sep 26, 1997
KERR NEXUS ONE BOTTLE ADHESIVE
K972858 · KLE
Sybron Dental Specialties, Inc.
Dental · 53d
Cleared Sep 26, 1997
ASLI
K973473 · IOR
Texin Industrial (International) , Ltd.
Physical Medicine · 11d
Cleared Sep 25, 1997
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · KDL
Cobe Renal Care, Inc.
Gastroenterology & Urology · 664d
Cleared Sep 25, 1997
W.M.E. GPS 1001
K961751 · IPF
Weaver Medical Electronics, Inc.
Physical Medicine · 507d
Cleared Sep 25, 1997
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
K964406 · JWO
Daxor Corporation
Hematology · 325d
Cleared Sep 25, 1997
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
K970061 · DQA
Datascope Corp.
Anesthesiology · 261d
Cleared Sep 25, 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL...
K971267 · JOH
Mallinckrodt Medical
Anesthesiology · 174d
Cleared Sep 25, 1997
UNICA 315 M CO2 SURGICAL LASER SYSTEM
K971821 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 132d
Cleared Sep 25, 1997
SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
K972199 · DPS
Marquette Electronics, Inc.
Cardiovascular · 106d
Cleared Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · LCP
Tosoh Medics, Inc.
Hematology · 100d
Cleared Sep 25, 1997
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 99d
Cleared Sep 25, 1997
HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH...
K972418 · MKJ
Heartstream, Inc.
Cardiovascular · 90d
Cleared Sep 25, 1997
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
K972460 · JDI
Osteonics Corp.
Orthopedic · 86d
Cleared Sep 25, 1997
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K972463 · JEY
Biomedics
Dental · 86d
Cleared Sep 25, 1997
NPB-195 PULSE OXIMETER
K972468 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 86d
Cleared Sep 25, 1997
ALCOHOL REAGENT SET
K972725 · DIC
Pointe Scientific, Inc.,
Toxicology · 66d
Cleared Sep 25, 1997
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
K972761 · CFL
Sealite Sciences, Inc.
Chemistry · 63d
Cleared Sep 25, 1997
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
K972768 · HRX
Blackstone Medical, Inc.
Orthopedic · 63d
Cleared Sep 25, 1997
WAKO CH50 LINEARITY SET
K973055 · JIW
Wako Chemicals USA, Inc.
Immunology · 41d