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
92233–92256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 1997
DUAL OFFSET PERFECTA IMC HIP STEM
K972641 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Oct 09, 1997
GAMMA LOCKING NAIL SYSTEM
K972813 · HSB
Howmedica Corp.
Orthopedic · 72d
Cleared Oct 09, 1997
GLUCOTREND BASIC SYSTEM
K972876 · LFR
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015 · MBI
Bonutti Research
Orthopedic · 57d
Cleared Oct 09, 1997
TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
K973062 · EFA
Medidenta Intl., Inc.
Dental · 52d
Cleared Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK...
K973075 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177 · JJF
Diamedix Corp.
Chemistry · 45d
Cleared Oct 09, 1997
UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
K973418 · IOR
Assembly Required Dist., Inc.
Physical Medicine · 29d
Cleared Oct 08, 1997
MD100 & MM150
K963913 · EAM
Konica Medical Corp.
Radiology · 373d
Cleared Oct 08, 1997
CM & CM DS-7
K963914 · IXA
Konica Medical Corp.
Radiology · 373d
Cleared Oct 08, 1997
GELBFISH ENDO-VAC SYSTEM
K970233 · MCW
Gary A. Gelbfish
Cardiovascular · 260d
Cleared Oct 08, 1997
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
K971273 · DQA
Bio-Tek Instruments, Inc.
Anesthesiology · 184d
Cleared Oct 08, 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 152d
Cleared Oct 08, 1997
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
K971877 · DTZ
Dideco S.P.A.
Cardiovascular · 140d
Cleared Oct 08, 1997
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · IZL
Sterne Equipment Co., Ltd.
Radiology · 118d
Cleared Oct 08, 1997
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
K972569 · EGS
Nsk Nakanishi, Inc.
Dental · 90d
Cleared Oct 08, 1997
DISSECTRON PORTABLE UNIT
K972612 · LBK
Satelec
Neurology · 86d
Cleared Oct 08, 1997
MANIFOLD
K972654 · DTL
Medical Specialties Intl., Inc.
Cardiovascular · 85d
Cleared Oct 08, 1997
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K972726 · JSM
Medical Packaging Corp.
Microbiology · 79d
Cleared Oct 08, 1997
DEY VIAL SODIUM CHLORIDE 3%
K972778 · CAF
Dey Laboratories, Inc.
Anesthesiology · 75d
Cleared Oct 08, 1997
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 08, 1997
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER...
K972922 · EMX
Interview Medical Technology Corp.
Ear, Nose, Throat · 61d
Cleared Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
K972926 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 08, 1997
ROTOGRAPH PLUS
K972968 · EHD
Chicago X-Ray Systems, Inc.
Radiology · 58d