FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135913–135936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1988
DENT SLEEVE MANOMETRIC CATHETER
K881310 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 53d
Cleared May 20, 1988
PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.
K881493 · LKG
Pharmacia Deltec, Inc.
General Hospital · 42d
Cleared May 20, 1988
PORT-A-CATH PORTAL INTRODUCER FORCEPS
K881690 · LKG
Pharmacia Deltec, Inc.
General Hospital · 31d
Cleared May 20, 1988
NATIONAL-STANDARD NEEDLE HOLDER
K881956 · KNW
N-S Medical Products
Gastroenterology & Urology · 10d
Cleared May 20, 1988
HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
K881957 · KNW
N-S Medical Products
Gastroenterology & Urology · 10d
Cleared May 19, 1988
IQK-200
K881313 · BTR
Medical Repackers Co.
Anesthesiology · 52d
Cleared May 19, 1988
EXTERNAL PACEMAKER WIRE DRESSING CHANGE
K881356 · LDF
Neal & Assoc., Inc.
Cardiovascular · 52d
Cleared May 19, 1988
RIDE-LITE 9000 SERIES WHEELCHAIR
K881951 · IOR
Invacare Corp.
Physical Medicine · 9d
Cleared May 18, 1988
OCO PREPARATIONS
K874396 · EJF
Williams Importing Company, Inc.
Dental · 203d
Cleared May 18, 1988
INTRA-AORTIC BALLOON PUMP MODEL KAAT
K875036 · DSP
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 18, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
K875370 · JAK
Shimadzu Precision Instruments, Inc.
Radiology · 139d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K880167 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 120d
Cleared May 18, 1988
SPECTRUM
K880774 · ELL
Dentsply Intl.
Dental · 82d
Cleared May 18, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
K881003 · DXN
Healthcheck Corp.
Cardiovascular · 70d
Cleared May 18, 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · DQA
Hewlett-Packard Co.
Anesthesiology · 63d
Cleared May 18, 1988
IMPULSE TVC (RICHARDS, OMNI, MARCON)
K881143 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 62d
Cleared May 18, 1988
ACCUTONE IN-THE-EAR HEARING AID
K881193 · ESD
Interstate Hearing Aid Service
Ear, Nose, Throat · 58d
Cleared May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
K881279 · DTI
Baxter Healthcare Corp
Cardiovascular · 57d
Cleared May 18, 1988
COAG-A-MATE(R) XM
K881281 · GKP
Organon Teknika Corp.
Hematology · 54d
Cleared May 18, 1988
MODEL 375 ECG
K881328 · DPS
Birtcher Corp.
Cardiovascular · 50d
Cleared May 18, 1988
MODIFIED IDS RAPID NH SYSTEM
K881501 · JSX
Innovative Diagnostic Systems, Inc.
Microbiology · 37d
Cleared May 18, 1988
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688 · IZJ
Adac Laboratories
Radiology · 29d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K881732 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 26d
Cleared May 18, 1988
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · GBS
Sheridan Catheter Corp.
General & Plastic Surgery · 15d