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
164185–164208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1981
ETHYL ALCOHOL SERUM CALIBRATOR
K810466 · DNN
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · DMT
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
EMIT-ST SERUM CONTROLS
K810468 · DIF
Syva Co.
Toxicology · 11d
Cleared Mar 06, 1981
DIGITAL DISPENSING PUMP
K810509 · JQW
Dynatech Corp.
Chemistry · 10d
Cleared Mar 06, 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · JJQ
Beckman Instruments, Inc.
Chemistry · 10d
Cleared Mar 06, 1981
NEO-WAVE SYSTEM
K810543 · INX
Gaymar Industries, Inc.
Physical Medicine · 7d
Cleared Mar 05, 1981
CPS-1000
K802890 · DTN
Gics Pharmaceuticals
Cardiovascular · 108d
Cleared Mar 05, 1981
MARK 500 SYSTEM
K810073 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 51d
Cleared Mar 05, 1981
PHERESIS NEEDLE ASSEMBLY
K810076 · GAA
Haemonetics Corp.
General & Plastic Surgery · 51d
Cleared Mar 05, 1981
AM 420 MICROPROCESSOR
K810163 · DXG
Honeywell, Inc.
Cardiovascular · 42d
Cleared Mar 05, 1981
PROXIMAL FERMORAL HIP REPLACEMENT
K810258 · JDO
Biomet, Inc.
Orthopedic · 34d
Cleared Mar 05, 1981
FANCY TAN SUNBED
K810366 · LEJ
Fancy Tan, Inc.
Radiology · 21d
Cleared Mar 05, 1981
MEADOX SZILAGYI GRAFT
K810376 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 21d
Cleared Mar 05, 1981
PRE-BYPASS FILTER
K810395 · KRJ
Texas Medical Products, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
STERILE PACKAGING
K810410 · DXY
Telectronics, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
USCI CARDIOVASCULAR CATHETER
K810412 · DQO
C.R. Bard, Inc.
Cardiovascular · 15d
Cleared Mar 05, 1981
SARNS MINI-SUCKER
K810416 · GCY
3M Health Care, Sarns
General & Plastic Surgery · 15d
Cleared Mar 04, 1981
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K802368 · DPS
Marquette Electronics, Inc.
Cardiovascular · 156d
Cleared Mar 04, 1981
NIKKISO ND-14 PARALLEL FLOW DIALYZER
K803068 · FJG
NIKKISO CO., LTD.
Gastroenterology & Urology · 90d
Cleared Mar 04, 1981
PROCEDURE & RECOVERY PATIENT SUIT
K803171 · FYB
Alba Health Care
General Hospital · 79d
Cleared Mar 04, 1981
EYETECH-VISION SCREENING SYSTEM
K803256 · HOX
Eyedex
Ophthalmic · 71d
Cleared Mar 04, 1981
STEREO AUDITORY TRAINER (MODEL PM228)
K810031 · EPF
Hc Electronics
Ear, Nose, Throat · 57d
Cleared Mar 04, 1981
ACCUFLO 100
K810074 · KOC
Renal Care Corp.
Gastroenterology & Urology · 50d
Cleared Mar 04, 1981
PORCELAIN POWDER FOR CLINICAL USE
K810096 · EIH
Dentsply Intl.
Dental · 49d