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
103057–103080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1995
BLADDER NECK SUPPORT PROTHESIS FITTING KIT
K933654 · HHW
Johnson & Johnson Medical, Inc.
Obstetrics & Gynecology · 646d
Cleared May 04, 1995
BODY POSITION INDICATOR, MODEL BPI1
K940013 · MNR
Pro-Tech, Inc.
Anesthesiology · 485d
Cleared May 04, 1995
FILTRYZER
K940910 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 433d
Cleared May 04, 1995
SYSTEM, IMAGE PROCESSING
K943156 · JAA
Image Technology, Inc.
Radiology · 308d
Cleared May 04, 1995
VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)
K944004 · IYO
Endosonics Corp.
Radiology · 261d
Cleared May 04, 1995
DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
K944833 · OMB
New England Medical Monitoring Co.
Neurology · 216d
Cleared May 04, 1995
TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT
K945319 · ITX
Tetra Corp.
Radiology · 184d
Cleared May 04, 1995
BCM 400CP
K946378 · IZI
B C Medical , Ltd.
Radiology · 132d
Cleared May 04, 1995
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
K950431 · LMD
Open Mri, Inc.
Radiology · 91d
Cleared May 04, 1995
CCD ENDOCAM 5501
K950502 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 87d
Cleared May 04, 1995
KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)
K951005 · IZQ
Kenex , Ltd.
Radiology · 78d
Cleared May 04, 1995
IMAGING TABLE
K951146 · KXJ
Septa Corp.
Radiology · 52d
Cleared May 04, 1995
PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
K951372 · IZW
Philips Medical Systems, Inc.
Radiology · 38d
Cleared May 04, 1995
CVD BULLETT HI-FLO INFUSION CATHETER
K951503 · KRA
Cardiovascular Dynamics, Inc.
Cardiovascular · 37d
Cleared May 04, 1995
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · DRF
Boston Scientific Corp
Cardiovascular · 35d
Cleared May 03, 1995
JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT
K925469 · FKG
J.J. Skinner, Inc.
Gastroenterology & Urology · 916d
Cleared May 03, 1995
BAXTER BIOSTAT 1000 UREA MONITOR
K925581 · KXM
Baxter Healthcare Corp
Gastroenterology & Urology · 909d
Cleared May 03, 1995
AMS 3000M
K936009 · CAP
Acutronic Medical Systems AG
Anesthesiology · 503d
Cleared May 03, 1995
RW RESUCITAIRE INFANT RADIANT WARMER
K940951 · FMT
Air-Shields, Inc.
General Hospital · 427d
Cleared May 03, 1995
QCT-BONE MINERAL ANALYSIS PHANTOM
K941126 · KGI
Image Analysis, Inc.
Radiology · 420d
Cleared May 03, 1995
OR TOWEL
K941802 · KKX
Hermitage Hospital Products, Inc.
General Hospital · 386d
Cleared May 03, 1995
ISOTRON III
K941815 · LIH
Excel Tech. , Ltd.
Neurology · 386d
Cleared May 03, 1995
OXYCHEK OXYGEN ANALYZER
K942593 · CCL
Nidek Medical Products, Inc.
Anesthesiology · 336d
Cleared May 03, 1995
PACETRAK
K943123 · DXH
Universal Medical, Inc.
Cardiovascular · 308d