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
86209–86232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 21, 1999
SURGEON'S GLOVES
K984395 · KGO
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 164d
Cleared May 21, 1999
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346 · JGS
Bayer Corp.
Chemistry · 106d
Cleared May 21, 1999
SONOTOME
K990572 · LFL
Sonokinetics, Inc.
General & Plastic Surgery · 87d
Cleared May 21, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
K990878 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 66d
Cleared May 21, 1999
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
K990882 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 66d
Cleared May 21, 1999
EASYSAFE RETRACTING NEEDLE SYRINGE
K991039 · FMF
Saf-T-Med, Inc.
General Hospital · 53d
Cleared May 21, 1999
SMARTEMP
K991270 · EBG
Parkell, Inc.
Dental · 38d
Cleared May 21, 1999
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS...
K991317 · KGO
Safeskin Corp.
General Hospital · 32d
Cleared May 21, 1999
ASCENT KNEE SYSTEM
K991428 · JWH
Biomet, Inc.
Orthopedic · 25d
Cleared May 21, 1999
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K991644 · KLK
Linde Medical Sensors AG
Anesthesiology · 8d
Cleared May 21, 1999
CENTRAFIX EXTERNAL FIXATOR
K991732 · JEC
Owandar Medical, Ltd.
Orthopedic
Cleared May 20, 1999
WRIST BLOOD PRESSURE METER MODEL SE-330
K973078 · DPW
Sein Electronics Co., Ltd.
Cardiovascular · 640d
Cleared May 20, 1999
WALKCARE P200 SYSTEM
K973592 · JOW
A.Stein - Regulatory Affairs Consulting
Cardiovascular · 605d
Cleared May 20, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
K983840 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 202d
Cleared May 20, 1999
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000,...
K984270 · MED
Roger L. Goodman, D.D.S., P.C.
General Hospital · 171d