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
87505–87528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 18, 1998
BREATHTIQUE TONGUE SCRAPER
K983087 · LCN
Custom Medical Arts, Inc.
Dental · 76d
Cleared Nov 18, 1998
ACON MIDSTREAM PREGNANCY TEST
K983090 · LCX
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Nov 18, 1998
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
K983113 · CEP
Syntron Bioresearch, Inc.
Chemistry · 75d
Cleared Nov 18, 1998
AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S...
K983168 · EFB
Ora Innovations, Inc.
Dental · 69d
Cleared Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Nov 18, 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188 · LDJ
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST METHAMPHETAMINES TEST KIT
K983189 · LAF
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST OPIATES TEST KIT
K983190 · DJG
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST COCAINE TEST KIT
K983191 · DIO
Ameritek, Inc.
Toxicology · 68d