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
81697–81720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2000
INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
K994410 · LDJ
Alfa Scientific Designs, Inc.
Toxicology · 176d
Cleared Jun 20, 2000
3D-MSPECT
K001026 · KPS
The Reagents of the University of...
Radiology · 82d
Cleared Jun 20, 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · JPA
Dade Behring, Inc.
Hematology · 78d
Cleared Jun 20, 2000
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
K001286 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 60d
Cleared Jun 20, 2000
BREAST IMMOBILIZATION DEVICE MR-BY 160
K001303 · MOS
Mri Devices Corp.
Radiology · 57d
Cleared Jun 20, 2000
SYNTHES (USA) ORIBITAL MESH PLATES
K001311 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Jun 20, 2000
MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
K001312 · MOS
Igc-Medical Advances, Inc.
Radiology · 55d
Cleared Jun 20, 2000
SIGNUM
K001360 · EBF
J.F. Jelenko & Co., Inc.
Dental · 53d
Cleared Jun 20, 2000
AURELUX Y 84 PREMIUM
K001477 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
AURECAST SUPER INLAY
K001478 · EJT
Aurex SA (Pty) , Ltd.
Dental · 40d
Cleared Jun 20, 2000
CALCIUM SULFATE PELLETS
K001559 · MQV
Howmedica Osteonics Corp.
Orthopedic · 32d
Cleared Jun 20, 2000
M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
K001711 · IYN
Agilent Technologies, Inc.
Radiology · 15d
Cleared Jun 20, 2000
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL...
K001733 · JDI
Zimmer, Inc.
Orthopedic · 13d
Cleared Jun 20, 2000
MEDI-CULT M3 MEDIUM
K991331 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d
Cleared Jun 20, 2000
MEDI-CULT HYALURONIDASE
K991334 · MQL
Medicult A/S
Obstetrics & Gynecology · 428d
Cleared Jun 20, 2000
OCD2001
K992935 · NFB
Contemporary Products, Inc.
Anesthesiology · 294d
Cleared Jun 20, 2000
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
K993125 · FMI
Safety Medical Supply Int,., Inc.
General Hospital · 274d
Cleared Jun 20, 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176 · KGI
Norland Medical Systems, Inc.
Radiology · 272d
Cleared Jun 20, 2000
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
K993625 · HIF
Genicon, LC
Obstetrics & Gynecology · 238d
Cleared Jun 19, 2000
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
K000754 · JNB
Quantase , Ltd.
Chemistry · 103d
Cleared Jun 19, 2000
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 98d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484 · JIX
Alko Diagnostic Corp.
Chemistry · 39d
Cleared Jun 19, 2000
ADVANTAGE THC TEST
K001567 · LDJ
Advantage Diagnostics Corp.
Toxicology · 31d
Cleared Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · JJY
Avl Scientific Corp.
Chemistry · 24d