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
91873–91896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 25, 1997
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K973109 · CIG
Synermed, Inc.
Chemistry · 37d
Cleared Sep 25, 1997
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · LDJ
Phamatech
Toxicology · 36d
Cleared Sep 25, 1997
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
K973143 · GGP
Universal Reagents, Inc.
Hematology · 34d
Cleared Sep 25, 1997
ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR
K973159 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 34d
Cleared Sep 25, 1997
OSTEO BOS SYSTEM IN STAINLESS STEEL
K973204 · HRS
Osteonics Corp.
Orthopedic · 30d
Cleared Sep 25, 1997
FRESH CELLS VERO
K973209 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS NCI H292
K973210 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS MV1LU
K973211 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS WI-38
K973212 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d