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
91897–91920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 24, 1997
DISETRONIC PENFINE INJECTION PEN NEEDLE
K973339 · FMI
Disetronic Medical Systems
General Hospital · 19d
Cleared Sep 23, 1997
ANGIOMAT ILLUMENA
K963071 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 412d
Cleared Sep 23, 1997
SHELHIGH PERICARDIAL PATCH
K964467 · DXZ
Shelhigh, Inc.
Cardiovascular · 320d
Cleared Sep 23, 1997
PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND...
K970906 · CBZ
Diametrics Medical, Ltd.
Anesthesiology · 195d
Cleared Sep 23, 1997
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
K971150 · GCJ
Mist, Inc.
General & Plastic Surgery · 179d
Cleared Sep 23, 1997
CAPNOXYGEN MASK
K971229 · CCK
Medsys, Inc.
Anesthesiology · 174d
Cleared Sep 23, 1997
MULTISPECT 2 511 KEV COLLIMATOR
K972360 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 23, 1997
V40 ZIRCONIA FEMORAL HEADS
K972361 · LZO
Howmedica, Inc.
Orthopedic · 90d
Cleared Sep 23, 1997
IMNET DICOM NETWORK AGENT
K972366 · LMD
Imnet Systems, Inc.
Radiology · 90d