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
85897–85920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1999
SYNTHES QUICK LOCK IMF SYSTEM
K991004 · DYX
Synthes (Usa)
Dental · 90d
Cleared Jun 23, 1999
RC BUTTRESS
K991009 · MAI
Biomet, Inc.
Orthopedic · 89d
Cleared Jun 23, 1999
ORASCOPE
K991011 · EIA
Fiberdent Corp.
Dental · 89d
Cleared Jun 23, 1999
MINIMED 407C INFUSION PUMP, MODEL 407C
K991013 · FRN
Medtronic Minimed
General Hospital · 89d
Cleared Jun 23, 1999
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC,...
K991021 · ELC
Nsk Nakanishi, Inc.
Dental · 86d
Cleared Jun 23, 1999
ACTIWATCH-SCORE
K991033 · GWQ
Mini-Mitter Co., Inc.
Neurology · 86d
Cleared Jun 23, 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
K991037 · JDS
Modular Cutting Systems, Inc.
Orthopedic · 86d
Cleared Jun 23, 1999
METACARPAL FIXATION SYSTEM
K991064 · HTY
Medcanica, Inc.
Orthopedic · 84d
Cleared Jun 23, 1999
CELL-DYN 1200 SYSTEM
K991142 · GKZ
Abbott Laboratories
Hematology · 79d
Cleared Jun 23, 1999
DCI ENDOSCOPE
K991171 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 77d
Cleared Jun 23, 1999
HYDROTONE-THERMAL CAPSULE SYSTEM
K991184 · ILJ
Nats Corp.
Physical Medicine · 76d
Cleared Jun 23, 1999
DEFLECTABLE ELECTROSURGICAL PROBES
K991190 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 76d
Cleared Jun 23, 1999
ENDOSCOPIC FIBEROPTIC CABLE
K991208 · HBI
Isolux America
General & Plastic Surgery · 75d
Cleared Jun 23, 1999
DCI ENDOSCOPE
K991228 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 72d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · LZA
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 23, 1999
ACCUTRED SHOE
K991313 · IRN
Orthopedic Technology Research, Inc.
Physical Medicine · 68d
Cleared Jun 23, 1999
HAL SCOPE HOLDER SYSTEM
K991548 · KKX
Noved Medical
General Hospital · 51d
Cleared Jun 23, 1999
JELTEMP
K991564 · EBG
J.F. Jelenko & Co., Inc.
Dental · 49d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION...
K991743 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH...
K991744 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A...
K991745 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH...
K991746 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150...
K991748 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50...
K991749 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d