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
119041–119064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1991
KLEER(TM) ORTHODONTIC BRACKET
K914616 · EJF
Ormco Corp.
Dental · 34d
Cleared Nov 19, 1991
RELIEF BAND (T.E.N.S. DEVICE)
K901704 · GZJ
Maven Labs, Inc.
Neurology · 586d
Cleared Nov 19, 1991
MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS
K911111 · EHJ
Vermont Diamond Instruments
Dental · 257d
Cleared Nov 19, 1991
INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM
K911114 · ITX
Interson Corp.
Radiology · 257d
Cleared Nov 19, 1991
WALKAWAY TM 40
K911400 · LRG
Baxter Healthcare Corp
Microbiology · 235d
Cleared Nov 19, 1991
EXMOOR SILICONE RUBBER SHEET
K911503 · KHJ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 230d
Cleared Nov 19, 1991
QUANTA LITE(TM) ACA
K911680 · MID
Inova Diagnostics, Inc.
Immunology · 218d
Cleared Nov 19, 1991
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
K911795 · LXV
Breg, Inc.
Ear, Nose, Throat · 211d
Cleared Nov 19, 1991
ES1600 PARAMEDIC TELEPHONE
K912281 · DXH
Epic Systems, Inc.
Cardiovascular · 180d
Cleared Nov 19, 1991
CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111
K912516 · IZZ
Continental X-Ray Corp.
Radiology · 166d
Cleared Nov 19, 1991
INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
K912600 · ITX
Intertherapy, Inc.
Radiology · 162d
Cleared Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · CEC
Serono-Baker Diagnostics, Inc.
Chemistry · 137d
Cleared Nov 19, 1991
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K913427 · JCM
Creative Laboratory Products, Inc.
Hematology · 110d
Cleared Nov 19, 1991
SUMO GLASS IONOMER CEMENT
K913519 · EMA
Ortho Source
Dental · 104d
Cleared Nov 19, 1991
STATVIEW
K913755 · LLZ
Image Systems, Inc.
Radiology · 90d
Cleared Nov 19, 1991
PRESSURE GUARD
K913772 · HIF
Beacon Laboratories, Inc.
General & Plastic Surgery · 88d
Cleared Nov 19, 1991
MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
K913805 · DTE
Pace Medical
Cardiovascular · 85d
Cleared Nov 19, 1991
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · DPW
Hewlett-Packard Co.
Radiology · 85d
Cleared Nov 19, 1991
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT
K913928 · FAD
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 77d
Cleared Nov 19, 1991
HMS-5000
K914085 · BZG
Vitalog Monitoring,Inc.
Anesthesiology · 74d
Cleared Nov 19, 1991
POWER RECLINER WHEELCHAIR
K914091 · ITI
Everest & Jennings, Inc.
Physical Medicine · 69d
Cleared Nov 19, 1991
ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK
K914226 · JZB
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 60d
Cleared Nov 19, 1991
ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP
K914358 · EYB
Hobbs Medical, Inc.
Gastroenterology & Urology · 49d
Cleared Nov 19, 1991
CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY
K914510 · JFN
Beckman Instruments, Inc.
Chemistry · 41d