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
145129–145152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1986
FENLIN TOTAL SHOULDER
K852137
Zimmer, Inc.
Orthopedic · 272d
Cleared Feb 12, 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · HSB
Zimmer, Inc.
Orthopedic · 195d
Cleared Feb 12, 1986
VERIFLEX
K854410 · KPZ
Old Delft Corp. of America
Radiology · 103d
Cleared Feb 12, 1986
TBX MEDICAL X-RAY TABLE
K854459 · IXJ
Gendex Corp.
Radiology · 98d
Cleared Feb 12, 1986
EMPI MODEL 720 NMS
K854774 · IPF
Empi
Physical Medicine · 75d
Cleared Feb 12, 1986
EMPI MODEL 730 NMS
K854775 · IPF
Empi
Physical Medicine · 75d
Cleared Feb 12, 1986
MULTIPLE I.V. SETS
K854804 · FPA
C. B. Dumont Company, Inc.
General Hospital · 72d
Cleared Feb 12, 1986
LS1000 SURGICAL ASPIRATOR II
K854844 · BTA
Engineering, Inc.
General & Plastic Surgery · 70d
Cleared Feb 12, 1986
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863 · LDR
Travenol Laboratories, S.A.
General Hospital · 69d
Cleared Feb 12, 1986
SANDHILL ELECTRONIC CALIPER
K854933 · IXC
Sandhill
Radiology · 64d
Cleared Feb 12, 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · DTD
Telectronics, Inc.
Cardiovascular · 62d
Cleared Feb 12, 1986
RATEMINDER III INFUSION DEVICE
K855000 · LDR
American Edwards Laboratories
General Hospital · 61d
Cleared Feb 12, 1986
SWELL-RELIEF
K855004 · DRM
D.A. Schulman, Inc.
Cardiovascular · 61d
Cleared Feb 12, 1986
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · DQK
Marquette Electronics, Inc.
Cardiovascular · 56d
Cleared Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Feb 12, 1986
UPRIGHT BUCKY STAND/MOUNT
K855161 · KPR
X-Ray Systems
Radiology · 48d
Cleared Feb 12, 1986
ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR
K855162 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 48d
Cleared Feb 12, 1986
RONDEX CPR VALVE
K855218 · CBP
Kondex Products, Inc.
Anesthesiology · 44d
Cleared Feb 12, 1986
SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
K860030 · BTA
Surgidyne, Inc.
General & Plastic Surgery · 37d
Cleared Feb 12, 1986
MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
K860102 · FHP
Endotherapeutics
Gastroenterology & Urology · 33d
Cleared Feb 12, 1986
MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE
K860103 · GCP
Endotherapeutics
Gastroenterology & Urology · 33d
Cleared Feb 12, 1986
DOUBLE-JECT TRANSFER NEEDLE
K860113 · LHI
Medimix Products, Inc.
General Hospital · 30d
Cleared Feb 12, 1986
SUM TAN VI
K860144 · FTC
Nae, Inc.
General & Plastic Surgery · 28d
Cleared Feb 12, 1986
BEAVER MICRO-GEM GAUGE BLOCK
K860305 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 15d