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
92401–92424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 25, 1997
FRESH CELLS LLC-MK2
K973213 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS HFF
K973214 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
K973379 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 17d
Cleared Sep 25, 1997
CHEMMATE LCA
K973393 · DEH
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Sep 25, 1997
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM...
K973469 · JJY
Consolidated Technologies, Inc.
Chemistry · 21d
Cleared Sep 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517 · JJY
Johnson & Johnson Clinical...
Chemistry · 8d
Cleared Sep 24, 1997
KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE
K971038 · DPS
Kontron Instruments , Ltd.
Cardiovascular · 188d
Cleared Sep 24, 1997
DUO-LITE PHOTOTHERAPY SYSTEM
K971256 · LBI
Air-Shields, Inc.
General Hospital · 173d
Cleared Sep 24, 1997
OLYMPIC BILI-BASSINET
K971601 · LBI
Olympic Medical Corp.
General Hospital · 146d
Cleared Sep 24, 1997
RI-MEGA
K972377 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 24, 1997
SANAPHON N
K972378 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 24, 1997
PRECISA N
K972379 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 24, 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · CHH
Reagents Applications, Inc.
Chemistry · 89d
Cleared Sep 24, 1997
SPLINT IT
K972985 · ELS
Jeneric/Pentron, Inc.
Dental · 44d
Cleared Sep 24, 1997
VIOLA II DENTAL CAMERA SYSTEM
K973035 · EIA
Innovative Medical Systems, Inc.
Dental · 41d