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
85273–85296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1999
SILVERSTEIN MICROWICK
K991670 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 26, 1999
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K991841 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Aug 26, 1999
THERMOFLEX SYSTEM
K991847 · KNS
Argomed, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 26, 1999
OSTEOPLAST, MODEL POP200
K991854 · MQV
Interpore Cross Intl.
Orthopedic · 86d
Cleared Aug 26, 1999
PASCO MIC AND MIC/ID PANELS
K991925 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 26, 1999
PICCOLO METLYTE 7 REAGENT DISC
K992140 · JLB
Abaxis, Inc.
Chemistry · 63d
Cleared Aug 26, 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 56d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · GGN
Pacific Hemostasis
Hematology · 50d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 2
K992279 · GGN
Pacific Hemostasis
Hematology · 50d
Cleared Aug 26, 1999
URINE DRUG SCREENING CONTROL
K992395 · DIF
Seracare Technology
Toxicology · 38d
Cleared Aug 26, 1999
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
K992397 · JHI
Cenogenics Corp.
Chemistry · 38d
Cleared Aug 26, 1999
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY...
K992589 · LPL
Opti-Centre Laboratories
Ophthalmic · 24d
Cleared Aug 25, 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · FRG
Allegiance Healthcare Corp.
General Hospital · 308d
Cleared Aug 25, 1999
MED-RX EXTENSION SETS
K990777 · FPA
Benlan, Inc.
General Hospital · 169d
Cleared Aug 25, 1999
REDI-TEST PCP
K991698 · LCM
Redwood Biotech, Inc.
Toxicology · 99d
Cleared Aug 25, 1999
N-395 PULSE OXIMETER, MODEL N-395
K991823 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 89d
Cleared Aug 25, 1999
MINIJECT
K991888 · EJI
Spartan Ultrasonics, Inc.
Dental · 84d
Cleared Aug 25, 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · LZA
Safeskin Corp.
General Hospital · 68d
Cleared Aug 25, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 58d
Cleared Aug 25, 1999
POST CEMENT HI-X
K992248 · EBF
Bisco, Inc.
Dental · 50d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494 · KNT
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Aug 25, 1999
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992496 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 25, 1999
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 24, 1999
NEPTUNE WASTE MANAGEMENT SYSTEM
K990037 · FYD
American Immuno Tech
General Hospital · 230d