FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85729–85752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1999
PASS/FAIL CHALLENGE PACK
K991276 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 89d
Cleared Jul 12, 1999
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
K991285 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
K991297 · GEX
Medart Corp.
General & Plastic Surgery · 88d
Cleared Jul 12, 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300 · BWF
Dhd Healthcare Corp.
Anesthesiology · 87d
Cleared Jul 12, 1999
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
K991303 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 87d
Cleared Jul 12, 1999
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY
K991336 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 84d
Cleared Jul 12, 1999
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
K991377 · GCJ
Omnisonics Medical Technologies
General & Plastic Surgery · 82d
Cleared Jul 12, 1999
PARIETENE POLYPROPYLENE MESH
K991400 · FTL
Sofradim Production
General & Plastic Surgery · 81d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485 · LPH
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 12, 1999
CMV BRITE TURBO KIT
K991650 · LIN
Biotest Diagnostics Corp.
Microbiology · 60d
Cleared Jul 12, 1999
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
K991900 · OLV
Excel Tech. , Ltd.
Neurology · 38d
Cleared Jul 12, 1999
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
K991917 · JJW
Metrika, Inc.
Chemistry · 35d
Cleared Jul 12, 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
K991940 · KGO
Brightway Holdings Sdn. Bhd.
General Hospital · 33d
Cleared Jul 12, 1999
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50...
K992031 · LYY
Shanghai Changzheng Latex Factory
General Hospital · 26d
Cleared Jul 12, 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE...
K992065 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 12, 1999
SCATTERFREE LATERAL EMITTING FIBER
K992083 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 21d
Cleared Jul 12, 1999
CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
K992084 · GEX
Cynosure, Inc.
General & Plastic Surgery · 21d
Cleared Jul 12, 1999
ETI-EA-G ASSAY
K992191 · LSE
DiaSorin, Inc.
Microbiology · 14d
Cleared Jul 12, 1999
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
K992208 · IYO
Ge Medical Systems, Inc.
Radiology · 12d
Cleared Jul 12, 1999
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP
K992230 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 10d
Cleared Jul 09, 1999
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE...
K983504 · CGA
Medisense, Inc.
Chemistry · 276d
Cleared Jul 09, 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · CCL
Invacare Corp.
Anesthesiology · 220d
Cleared Jul 09, 1999
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640 · MYI
Id Biomedical Corp.
Microbiology · 133d
Cleared Jul 09, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST...
K990649 · CGA
Bayer Corp.
Chemistry · 130d