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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135313–135336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1988
BIOSOUND MMI ULTRASOUND
K871442 · JOP
Biosound, Inc.
Cardiovascular · 403d
Cleared May 20, 1988
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
K874377 · LXT
Harrington Arthritis Research Center
Orthopedic · 207d
Cleared May 20, 1988
CONTAIN(TM)
K874505 · GCX
Arbor Technologies, Inc.
General Hospital · 200d
Cleared May 20, 1988
EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER
K874850 · GZO
Epi-Scan Corp.
Neurology · 169d
Cleared May 20, 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · FRN
Y
General Hospital · 142d
Cleared May 20, 1988
EMERGENCY-CLEAN UP(TM) ECP
K880306 · EXB
Cdc Products Corp.
Gastroenterology & Urology · 116d
Cleared May 20, 1988
MODIFIED EVA-MIX AND DI-MIX BAGS
K880506 · KPE
Gil-Med Industries C/O Kegan & Kegan,...
General Hospital · 102d
Cleared May 20, 1988
MONTGOMERY NERVE STIMULATOR
K880720 · ETN
Boston Medical Products, Inc.
Ear, Nose, Throat · 87d
Cleared May 20, 1988
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
K880871 · IMD
John Wagner Associates, Inc.
Physical Medicine · 80d
Cleared May 20, 1988
C-STAT/1000
K880876 · LHC
Sonne Medical, Inc.
General Hospital · 80d
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