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
84313–84336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · MMI
Ortho-Clinical Diagnostics, Inc.
Chemistry · 85d
Cleared Oct 08, 1999
RC TACK
K992377 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Oct 08, 1999
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · JDI
Implex Corp.
Orthopedic · 80d
Cleared Oct 08, 1999
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
K992507 · JTN
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Oct 08, 1999
TECHNOSANAT KRYO TSK 2005
K992536 · GEX
Technosanat Innovative Medizintechnik...
General & Plastic Surgery · 71d
Cleared Oct 08, 1999
AIRIS, AIRIS II
K992650 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 63d
Cleared Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 08, 1999
ACON COMBO PREGNANCY
K993065 · JHI
ACON Laboratories, Inc.
Chemistry · 25d
Cleared Oct 08, 1999
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077 · MEH
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Oct 08, 1999
PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI
K993088 · CAW
Puritan Bennett Corp.
Anesthesiology · 22d
Cleared Oct 08, 1999
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
K993098 · JIX
Data Medical Associates, Inc.
Chemistry · 22d
Cleared Oct 07, 1999
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · FOZ
Baxter Healthcare Corp
General Hospital · 283d
Cleared Oct 07, 1999
ANEROID SPHYGMOMANOMETER
K990638 · DXN
Genmed, Inc.
Cardiovascular · 223d
Cleared Oct 07, 1999
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990 · JAQ
Nucletron Corp.
Radiology · 197d
Cleared Oct 07, 1999
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
K991452 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 164d
Cleared Oct 07, 1999
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687 · EBI
Bosworth Co.
Dental · 143d
Cleared Oct 07, 1999
AIRFLOW HANDY
K991857 · EFB
Electro Medical Systems, Inc.
Dental · 128d
Cleared Oct 07, 1999
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
K992028 · LPN
Allergan, Inc.
Ophthalmic · 113d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Boston Scientific Corp
Cardiovascular · 90d
Cleared Oct 07, 1999
BEACON-P, MODEL 211059
K992335 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 86d
Cleared Oct 07, 1999
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K992450 · KPS
Emory University
Radiology · 77d
Cleared Oct 07, 1999
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
K992575 · LLZ
Infimed, Inc.
Radiology · 66d
Cleared Oct 07, 1999
ECG MINIMONITOR, MODEL CG-5000
K992696 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Oct 07, 1999
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · ETN
Xomed, Inc.
Ear, Nose, Throat · 43d