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
86665–86688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 31, 1999
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
K990436 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 48d
Cleared Mar 31, 1999
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · DNN
Emd Chemicals, Inc.
Toxicology · 41d
Cleared Mar 31, 1999
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · ETA
Gyrus Ent LLC
Ear, Nose, Throat · 35d
Cleared Mar 31, 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · LLH
Intracel Corp.
Microbiology · 30d
Cleared Mar 31, 1999
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
K990923 · ETB
Heinz Kurz
Ear, Nose, Throat · 12d
Cleared Mar 30, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K982660 · CAC
Transfusion Technologies Corp.
Anesthesiology · 243d
Cleared Mar 30, 1999
SAPHLIFT
K990062 · MDM
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 81d
Cleared Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
K990075 · HQF
Light-Med(Usa), Inc.
Ophthalmic · 78d
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