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
85225–85248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 09, 1999
TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
K990761 · FRG
Tuttnauer U.S.A Co, Ltd.
General Hospital · 123d
Cleared Jul 09, 1999
SERUM CROSSLAPS ONE STEP ELISA
K990843 · JMM
Osteometer Biotech A/S
Chemistry · 116d
Cleared Jul 09, 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · GWM
Johnson & Johnson Professionals, Inc.
Neurology · 88d
Cleared Jul 09, 1999
ETCHING GEL
K991450 · EBF
Silicon-Und Composite Spezialitaten GmbH
Dental · 74d
Cleared Jul 09, 1999
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K991554 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 67d
Cleared Jul 09, 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 60d
Cleared Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700...
K991605 · GKZ
Abbott Laboratories
Hematology · 60d
Cleared Jul 09, 1999
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
K991624 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 59d
Cleared Jul 09, 1999
ACRON MC MODIFICATION
K991774 · EBI
GC America, Inc.
Dental · 45d