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
84505–84528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1999
MEDI-TEST COMBI 11
K991927 · JIL
Macherey-Nagel-Duren
Chemistry · 101d
Cleared Sep 17, 1999
FUTURA GLASS IONOMER SILVER REINFORCED
K991974 · EMA
Ab Ardent
Dental · 98d
Cleared Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 95d
Cleared Sep 17, 1999
GILTECH PLUS HYDROGEL SKIN DRESSING
K992094 · NAE
Giltech Plus, Inc.
General & Plastic Surgery · 88d
Cleared Sep 17, 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · HWC
Medartis AG
Orthopedic · 87d
Cleared Sep 17, 1999
PHAZX VLD-100
K992129 · GZO
Phazx Systems, Inc.
Neurology · 86d
Cleared Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Sep 17, 1999
CO2 GAS WARMER II, MODEL 6-800-00
K992381 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 63d
Cleared Sep 17, 1999
TOTAL HAEMOLYTIC COMPLEMENT RID KIT
K992488 · DAE
The Binding Site, Ltd.
Immunology · 53d
Cleared Sep 17, 1999
OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
K992670 · CBK
Instrumentation Industries, Inc.
Anesthesiology · 88d
Cleared Sep 17, 1999
CARDIOPHONICS 1000 MEMORY MONITOR
K992772 · DXH
Rlt Medical Assoc., Inc.
Cardiovascular · 30d
Cleared Sep 17, 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · MQN
Walter Lorenz Surgical, Inc.
Dental · 22d
Cleared Sep 17, 1999
COLOR BUFFED CEMENTED FEMORAL
K992903 · JDI
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 16, 1999
FRESH AIR
K981047 · CAW
Colorado Medtech, Inc.
Anesthesiology · 545d
Cleared Sep 16, 1999
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
K983717 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 330d
Cleared Sep 16, 1999
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
K984573 · LPN
Alcon Laboratories
Ophthalmic · 267d
Cleared Sep 16, 1999
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642 · JOP
Echocath, Inc.
Cardiovascular · 202d
Cleared Sep 16, 1999
MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
K992143 · JWY
Pasco Laboratories, Inc.
Microbiology · 84d
Cleared Sep 16, 1999
BEAR CUB 750 PSV
K992788 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 28d
Cleared Sep 16, 1999
SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
K992839 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 24d
Cleared Sep 16, 1999
STEPPING KINEMATIC IMAGING PLATFORM (SKIP)
K992892 · LNH
Magnetic Moments, LLC
Radiology · 20d
Cleared Sep 15, 1999
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · DRO
Tz Medical, Inc.
Cardiovascular · 369d
Cleared Sep 15, 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT...
K983232 · DRO
Tz Medical, Inc.
Cardiovascular · 366d
Cleared Sep 15, 1999
NUCLISENS CMV PP67
K983762 · LIN
Organon Teknika Corp.
Microbiology · 324d