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
86161–86184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1999
DAUM NEUROCUT NEUROBIOPSYNEEDLE
K990278 · KNW
Daum Corp.
Gastroenterology & Urology · 61d
Cleared Mar 30, 1999
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
K990608 · JJX
Bio-Rad
Chemistry · 34d
Cleared Mar 30, 1999
SPOROX II STERILIZING & DISINFECTING SOLUTION
K990703 · MED
Reckitt Benckiser, Inc.
General Hospital · 26d
Cleared Mar 30, 1999
TITANIUM VERSALOK
K990708 · KWP
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Mar 30, 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · MNI
Synthes Spine
Orthopedic · 22d
Cleared Mar 30, 1999
INDIGO LASEROPTIC TREATMENT SYSTEM
K990851 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 15d
Cleared Mar 30, 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 30, 1999
VIEWPOINT MICROSCOPE OPTION
K990860 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 14d
Cleared Mar 30, 1999
VIEWPOINT PASSIVE TOOL OPTION
K990868 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 14d
Cleared Mar 29, 1999
ADVANCED NIBP MODULE
K982641 · DXN
Johnson & Johnson Medical, Inc.
Cardiovascular · 243d
Cleared Mar 29, 1999
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
K983225 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 196d
Cleared Mar 29, 1999
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY...
K983496 · LPL
Opti-Centre Laboratories
Ophthalmic · 175d
Cleared Mar 29, 1999
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K984039 · LYY
Cranberry (M) Sdn. Bhd.
General Hospital · 137d
Cleared Mar 29, 1999
DRAGER SOLA SERIES, MODELS 1000/700/500/300
K984611 · FSY
Drager Medizintechnik GmbH
General & Plastic Surgery · 90d
Cleared Mar 29, 1999
FLEXISCOPE OPTOMODUL
K984641 · EIA
Schoelly Fiberoptic GmbH
Dental · 88d
Cleared Mar 29, 1999
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K990210 · LYY
Mexpo Intl., Inc.
General Hospital · 67d
Cleared Mar 29, 1999
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES
K990267 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 60d
Cleared Mar 29, 1999
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
K990299 · LZA
Shanghai Palomar Mountain Industries,...
General Hospital · 56d
Cleared Mar 29, 1999
TUTOPLUS IV ADMINISTRATION SET
K990388 · FPA
Myco Medical Supplies, Inc.
General Hospital · 49d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)
K990415 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 29, 1999
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990420 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 47d
Cleared Mar 26, 1999
MICRINS MICRO ANASTOMOSIS CLAMP
K982278 · DXC
Micrins Surgical, Inc.
Cardiovascular · 270d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gambro Healthcare
Gastroenterology & Urology · 256d
Cleared Mar 26, 1999
DORNIER MEDILAS H/2
K984591 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 88d