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
158065–158088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1983
VIDIVIEWER MOTORIZED MASS FILM VIEWER
K828566
Diversied P.A.
Radiology · 69d
Cleared Jan 03, 1983
F-100 FLUOROSCOPIC CONTROL AND XF-100 HIGH VOLTAGE GENERATOR
K828575
Interchange Manufacturer Corp.
Radiology · 60d
Cleared Jan 03, 1983
OPTHALAS PHOTOCOAGULATOR
K828585
Synemed, Inc.
Radiology · 41d
Cleared Jan 03, 1983
BEAM LIMITING DEVICE
K828605
Rinn Corp.
Radiology · 35d
Cleared Jan 03, 1983
MODEL PDX-4800 PROJECTION DIGITAL X-RAY SYSTEM
K828606
Adac Laboratories
Radiology · 35d
Cleared Jan 03, 1983
OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M
K828619
Ohmic , Ltd.
Radiology · 41d
Cleared Jan 03, 1983
UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305
K828654
Daavlin Co.
Radiology · 48d
Cleared Dec 30, 1982
ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
K822240 · KFX
American Mcgaw
Physical Medicine · 156d
Cleared Dec 30, 1982
PERFILM MEMBRANE DRESSING
K822467 · FRO
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 136d
Cleared Dec 30, 1982
PHADEBACT CSF TEST 20
K822810 · GTJ
Pharmacia, Inc.
Immunology · 101d
Cleared Dec 30, 1982
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · DSH
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Dec 30, 1982
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · CEW
Travenol Laboratories, S.A.
Chemistry · 87d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033 · DTB
Pacesetter Systems
Cardiovascular · 77d
Cleared Dec 30, 1982
BACKSTOP VALVE W/SIDE ARM
K823190 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
DISPOSABLE PLASTIC STOPCOCK
K823191 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
MODEL 8300 TESTER
K823197 · DRT
Medicon, Inc.
Cardiovascular · 65d
Cleared Dec 30, 1982
INJECTION FILL TUBE
K823238 · DXT
Vetrex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
VERTEX MONITORING CATHETER
K823253 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
REUSABLE METAL STOPCOCK
K823254 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823256 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
VENOUS RESERVOIR BAG #BMR-1400
K823272 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 58d
Cleared Dec 30, 1982
MODELS DPT 1000/DPT 1000NS
K823286 · DRS
Bio-Med Corp.
Cardiovascular · 56d
Cleared Dec 30, 1982
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · DRT
Intermedics, Inc.
Cardiovascular · 55d