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
92473–92496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548 · LYC
Etex Corp.
Dental · 403d
Cleared Aug 05, 1997
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
K963451 · IYE
Topslane
Radiology · 336d
Cleared Aug 05, 1997
AFFINITY BLOOD PUMP SYSTEM
K964017 · DTQ
Avecor Cardiovascular, Inc.
Cardiovascular · 302d
Cleared Aug 05, 1997
MEMORY STAPLE (20 SIZES AVAILABLE)
K964226 · JDR
Landos, Inc.
Orthopedic · 286d
Cleared Aug 05, 1997
ELECTRO-LITE ELITE POWERED WHEELCHAIR
K970575 · ITI
Damaco
Physical Medicine · 173d
Cleared Aug 05, 1997
PM 2002 CC PROLINE
K970812 · EHD
Planmeca Oy
Radiology · 153d
Cleared Aug 05, 1997
40 CC SUMO
K971673 · DSP
Boston Scientific Corp
Cardiovascular · 90d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 05, 1997
UNIGLOVES
K971731 · LYY
Uni-Glove (Usa), Inc.
General Hospital · 88d
Cleared Aug 05, 1997
AMPLAID 460
K971747 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 85d
Cleared Aug 05, 1997
PARI PEP THERAPY SYSTEM
K972042 · BWF
Pari Holding Co.
Anesthesiology · 64d
Cleared Aug 05, 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233 · HWC
Stryker Endoscopy
Orthopedic · 50d
Cleared Aug 05, 1997
V-12 LONG LIFE 675 HEARING AID
K972755 · ESD
Vista Labs
Ear, Nose, Throat · 14d
Cleared Aug 04, 1997
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
K970508 · IYO
Shimadzu Medical Systems
Radiology · 175d
Cleared Aug 04, 1997
PLASMA CATECHOLAMINE KIT
K972167 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 56d
Cleared Aug 04, 1997
RHINOCELL NASAL PACKINGS
K972459 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 04, 1997
BELL PROSTHESIS (PARTIAL)
K972492 · ETB
Heinz Kurz
Ear, Nose, Throat · 33d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526 · DJR
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Aug 04, 1997
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL...
K972585 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 25d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608 · JJY
Randox Laboratories, Ltd.
Immunology · 54d
Cleared Aug 01, 1997
RELIEFBAND TENS UNIT (MODIFICATION)
K961050 · GZJ
Maven Labs, Inc.
Neurology · 540d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1 TEST KIT
K964292 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · DER
Crestat Diagnostics, Inc.
Immunology · 276d