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
155665–155688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
I.V. TRANSFER NEEDLE
K832312 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 60d
Cleared Sep 12, 1983
VENTED I.V. TRANSFER NEEDLE
K832332 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 56d
Cleared Sep 12, 1983
ENDOSCOPIC CAMERA TV W/AUDIO
K832342 · KQM
Kamiya Tsusan Kaisha, Ltd.
General & Plastic Surgery · 62d
Cleared Sep 12, 1983
TWOFER NEEDLE
K832347 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 56d
Cleared Sep 12, 1983
CRYOPROBES MC-1400-CRYOSURG-CONSOLE
K832385 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 55d
Cleared Sep 12, 1983
DENTURE CLEANER
K832387 · JER
Tower Laboratories, Ltd.
Dental · 55d
Cleared Sep 12, 1983
QT-100 ELECTRONIC TEMP. MONITOR
K832391 · FLL
Science Development Corp.
General Hospital · 55d
Cleared Sep 12, 1983
SDC ORAL-RECTAL TEMP. PROBE
K832392 · FLL
Science Development Corp.
General Hospital · 55d
Cleared Sep 12, 1983
RECTAL TEMP. TELEMETRY MONITOR
K832404 · FLL
Xomed, Inc.
General Hospital · 54d
Cleared Sep 12, 1983
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
K832410 · FRN
Intermedics, Inc.
General Hospital · 53d
Cleared Sep 12, 1983
GASLINE FILTER #GF-10
K832411 · KRI
American Bentley
Cardiovascular · 53d
Cleared Sep 12, 1983
DEPROTEINIZING & CLEANING SOLUTION
K832415 · JGS
Shaban Mfg. Co.
Chemistry · 53d
Cleared Sep 12, 1983
OHIO TEMPERATURE SIMULATOR
K832418 · FMZ
Airco/Ohio Medical Products
General Hospital · 52d
Cleared Sep 12, 1983
ENVISION G21 I/A ENPAK
K832423 · HQC
Envision, Inc.
Ophthalmic · 52d
Cleared Sep 12, 1983
ENVISION G31 P.E. PAK
K832424 · HQC
Envision, Inc.
Ophthalmic · 52d
Cleared Sep 12, 1983
EASYTOUCH TRIGLYCERIDES REAGENT SET
K832426 · CDT
Worthington Diagnostic Systems
Chemistry · 52d
Cleared Sep 12, 1983
ULTRASONIC DENTAL PROPHYLAXIS UNIT
K832443 · ELC
California Technics, Inc.
Dental · 49d
Cleared Sep 12, 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
K832447 · KLT
American Dade
Chemistry · 49d
Cleared Sep 12, 1983
ANDROSTENEDIONE TEST SET 125I
K832452 · CIZ
Wien Laboratories, Inc.
Chemistry · 49d
Cleared Sep 12, 1983
A-GENT PHENOBARBITAL
K832457 · DLZ
Abbott Laboratories
Toxicology · 48d
Cleared Sep 12, 1983
TRIGLYCERIDE REAGENT-TRINDER-GPO
K832460 · JGY
Seppim, Inc.
Chemistry · 48d
Cleared Sep 12, 1983
AUTOPAK NEONATAL TSH RIA KIT
K832462 · JLW
Micromedic Systems
Chemistry · 48d
Cleared Sep 12, 1983
RAICHEM ALKALINE PHOSPHATASE REAGENT
K832463 · CJE
Reagents Applications, Inc.
Chemistry · 48d
Cleared Sep 12, 1983
T4-RIA SINGLE REAGENT
K832468 · CDX
Fairlake Laboratories
Chemistry · 49d