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
85681–85704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1999
SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K991415 · LYY
Supermax Sdn Bhd
General Hospital · 33d
Cleared May 26, 1999
14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
K991431 · MPB
Arrow Intl., Inc.
Gastroenterology & Urology · 30d
Cleared May 26, 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K991493 · LZA
Masju Sdn. Bhd.
General Hospital · 28d
Cleared May 26, 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · DQO
Cordis Corp.
Cardiovascular · 9d
Cleared May 25, 1999
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 120d
Cleared May 25, 1999
VITRON M
K990763 · EBI
Espe Dental AG
Dental · 78d
Cleared May 25, 1999
ALBUMIN BCG, MODEL AL 103-01
K990978 · CJW
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
BUN, MODEL BU 104-01
K990980 · CDQ
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL...
K990981 · CFR
A.P. Total Care, Inc.
Chemistry · 63d
Cleared May 25, 1999
CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
K991108 · KHS
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
K991109 · CGX
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO....
K991111 · CIC
A.P. Total Care, Inc.
Chemistry · 54d
Cleared May 25, 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · JMO
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
URIC ACID, MODEL UA112-01
K991247 · KNK
A.P. Total Care, Inc.
Chemistry · 43d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK),...
K991386 · CEP
Selfcare, Inc.
Chemistry · 34d
Cleared May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR...
K991466 · CEP
Selfcare, Inc.
Chemistry · 28d
Cleared May 24, 1999
LACTATION TECHNIQUES MODEL B
K981549 · HGX
Lactation Techniques, Inc.
Obstetrics & Gynecology · 389d
Cleared May 24, 1999
CLOUD 1 HUMIDIFICATION SYSTEM
K983862 · BTT
Respiratory Support Products, Inc.
Anesthesiology · 203d
Cleared May 24, 1999
BERACLAMP, MODEL BC-1
K990045 · KNA
Poamax LLC
Obstetrics & Gynecology · 138d
Cleared May 24, 1999
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · MNT
Respironics, Inc.
Anesthesiology · 90d
Cleared May 24, 1999
PELVX INCONTINENCE DISH, MODEL 301-306
K990593 · HHW
Deschutes Medical Products, Inc.
Obstetrics & Gynecology · 89d
Cleared May 24, 1999
HITACHI VERSIFLEX
K991231 · IZI
Hitachi Medical Systems America, Inc.
Radiology · 42d
Cleared May 21, 1999
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K984261 · CGA
Lifescan, Inc.
Chemistry · 175d
Cleared May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328 · IWB
Elekta Instrument AB
Radiology · 169d