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
139393–139416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1987
AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G
K870742 · KMJ
Span-America Medical Systems, Inc.
General Hospital · 100d
Cleared Jun 05, 1987
CONSULTANT BODY COMPOSITION ANALYZER
K871040 · DSB
Body Composition Analog, Inc.
Cardiovascular · 80d
Cleared Jun 05, 1987
DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER
K871149 · DRT
Iontec Corp.
Cardiovascular · 74d
Cleared Jun 05, 1987
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · DYB
Pacesetter Systems
Cardiovascular · 72d
Cleared Jun 05, 1987
CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300
K871221 · DRY
Cardiovascular Devices, Inc.
Cardiovascular · 70d
Cleared Jun 05, 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · DPS
Acuson Computed Sonography
Cardiovascular · 70d
Cleared Jun 05, 1987
COCAINE METABOLITE ENZYME IMMUNOASSAY KIT
K871305 · DIO
General Diagnostics
Toxicology · 65d
Cleared Jun 05, 1987
M-1 PRESSURE MONITOR
K871336 · CAP
Bio-Med Devices, Inc.
Anesthesiology · 63d
Cleared Jun 05, 1987
M-2 OXYGEN/TEMPERATURE MONITOR
K871337 · CCL
Bio-Med Devices, Inc.
Anesthesiology · 63d
Cleared Jun 05, 1987
MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
K871363 · DXN
Quinton, Inc.
Cardiovascular · 59d
Cleared Jun 05, 1987
BARD BIOPTY BIOPSY SYSTEM
K871390 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 05, 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · FMZ
Ohmeda Medical
General Hospital · 59d
Cleared Jun 05, 1987
SURVIVAL KIT, INDIV TROP TACT AIR CREW/PLASTIC BAG
K871459 · LRO
Frass Survival Systems, Inc.
General & Plastic Surgery · 53d
Cleared Jun 05, 1987
HYPERTENSION RISK DETECTOR(TM)
K871482 · DXN
Pearce Clinical Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 05, 1987
TELSTAR MODEL F3TS HEARING AID
K871518 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
FULL SHELL ITE HEARING AID
K871521 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
TELSTAR MODEL C HEARING AID
K871522 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Jun 05, 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 44d
Cleared Jun 05, 1987
BIRTHING ROOM WARMER
K871594 · FMT
Air-Shields, Inc.
General Hospital · 42d
Cleared Jun 05, 1987
THE KARL STORZ MODEL 28805 ARTHRO PUMP
K871621 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 39d
Cleared Jun 05, 1987
ELECTROTRACE DISP REST EKG ELECTRODE, CAT. ET1200
K871626 · DRX
Jason Marketing Co.
Cardiovascular · 39d
Cleared Jun 05, 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695 · LDJ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 05, 1987
DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5
K871696 · DKZ
Diagnostic Products Corp.
Toxicology · 36d
Cleared Jun 05, 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717 · HWE
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 32d