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
88009–88032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1998
STANDARD CHIN
K983754 · FWP
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
NASAL DORSAL SERIES
K983755 · FZE
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
SURGIFORM ANATOMICAL MALAR
K983756 · LZK
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 29d
Cleared Nov 20, 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · FRN
Abbott Laboratories
General Hospital · 30d
Cleared Nov 20, 1998
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO...
K983981 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d
Cleared Nov 20, 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
K984074 · JJY
Bio-Rad
Chemistry · 4d
Cleared Nov 19, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974738 · DZE
Astra Tech, Inc.
Dental · 335d
Cleared Nov 19, 1998
FACTS
K982010 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 164d
Cleared Nov 19, 1998
CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
K982243 · CAW
Canogen International , Ltd.
Anesthesiology · 147d
Cleared Nov 19, 1998
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K982544 · IMI
Rich-Mar Corp.
Physical Medicine · 121d
Cleared Nov 19, 1998
MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
K982937 · LHN
Victoreen, Inc.
Radiology · 90d
Cleared Nov 19, 1998
HEM-O-LOK MODEL NUMBERS 523900, 523970
K982941 · FZP
Weck Closure Systems
General & Plastic Surgery · 90d
Cleared Nov 19, 1998
HEM-O-LOCK, MODEL 523935
K982944 · FZP
Weck Closure Systems
General & Plastic Surgery · 90d
Cleared Nov 19, 1998
IMPRA HIGH POROSITY GRAFT
K983064 · DSY
Impra, Inc.
Cardiovascular · 78d
Cleared Nov 19, 1998
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
K983282 · KWP
Ohio Medical Instrument Co., Inc.
Orthopedic · 62d
Cleared Nov 18, 1998
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
K981199 · LRG
Dade Microscan, Inc.
Microbiology · 230d
Cleared Nov 18, 1998
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
K982315 · LQP
Alexon - Trend, Inc.
Microbiology · 140d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · LYR
Abbott Laboratories
Microbiology · 135d
Cleared Nov 18, 1998
NMT SAFETY SYRINGE
K982431 · MEG
New Medical Technology , Ltd.
General Hospital · 128d
Cleared Nov 18, 1998
AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT...
K982657 · MCW
Microvena Corp.
Cardiovascular · 111d
Cleared Nov 18, 1998
AUTO-LYTE BARBITURATES EIA
K982745 · DIS
OraSure Technologies, Inc.
Toxicology · 104d
Cleared Nov 18, 1998
PAINBUSTER INFUSION KIT
K982946 · MEB
I-Flow Corp.
General Hospital · 89d
Cleared Nov 18, 1998
AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
K983049 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 78d
Cleared Nov 18, 1998
AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
K983051 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 78d