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
70801–70824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Aug 08, 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 10d
Cleared Aug 07, 2003
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
K023735 · GCJ
Medsys, S.A.
General & Plastic Surgery · 273d
Cleared Aug 07, 2003
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316 · DRX
Inovise Medical, Inc.
Cardiovascular · 189d
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · JAQ
Nucletron Corp.
Radiology · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · MUJ
Nucletron Corp.
Radiology · 100d
Cleared Aug 07, 2003
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
K031432 · FRN
Hk Surgical, Inc.
General Hospital · 93d
Cleared Aug 07, 2003
HEATER COOLER UNIT, MODEL HCU 30
K031544 · DWC
Jostra AB
Cardiovascular · 83d
Cleared Aug 07, 2003
CORRESTORE PATCH SYSTEM
K031586 · DXZ
Somanetics Corp.
Cardiovascular · 78d
Cleared Aug 07, 2003
BIFURCATED ALLERGY SKIN TESTING NEEDLE
K031630 · SCL
Precision Medical Products, Inc.
General Hospital · 72d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Aug 07, 2003
PRACTICEBUILDER 1-2-3
K031778 · LLZ
Erad Imagemedical Corp.
Radiology · 58d
Cleared Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...
K031924 · JIT
Ortho-Clinical Diagnostics
Chemistry · 45d
Cleared Aug 07, 2003
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 41d
Cleared Aug 07, 2003
N LATEX IGM
K032014 · CFN
Dade Behring, Inc.
Immunology · 38d
Cleared Aug 07, 2003
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS...
K032035 · CZW
Beckman Coulter, Inc.
Immunology · 37d
Cleared Aug 06, 2003
NANMA ADJUSTABLE CONSTRICTION RING
K030119 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 205d
Cleared Aug 06, 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 191d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · MNI
Ebi, L.P.
Orthopedic · 99d
Cleared Aug 06, 2003
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
K031401 · KTT
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 93d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · MBH
Implex Corp.
Orthopedic · 90d
Cleared Aug 06, 2003
HEMOGLOBIN A1C REAGENT SET
K031539 · LCP
Pointe Scientific, Inc.,
Chemistry · 82d
Cleared Aug 06, 2003
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K031577 · JJY
Cliniqa Corporation
Chemistry · 78d
Cleared Aug 06, 2003
TOX AMMONIA CALIBRATOR
K031683 · JIX
Bayer Healthcare, LLC
Chemistry · 68d