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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111433–111456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1993
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660 · JJX
More Diagnostics
Chemistry · 148d
Cleared Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · CEC
Baxter Diagnostics, Inc.
Chemistry · 134d
Cleared Oct 28, 1993
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K933026 · CIG
Synermed, Inc.
Chemistry · 128d
Cleared Oct 28, 1993
PCI 2500
K933072 · IPF
Pci
Physical Medicine · 128d
Cleared Oct 28, 1993
HOBBS MEDICAL CLEANING BRUSH
K933354 · FEB
Hobbs Medical, Inc.
General Hospital · 111d
Cleared Oct 28, 1993
GENZYME A-AMYLASE TEST REAGENT
K933397 · JFJ
Genzyme Corp.
Chemistry · 108d
Cleared Oct 28, 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · JJY
Baxter Diagnostics, Inc.
Chemistry · 106d
Cleared Oct 28, 1993
BACTICARD STREP
K933514 · JTO
Remel Co.
Microbiology · 100d
Cleared Oct 28, 1993
LUMINOUS 150 FIBEROPTIC ILLUMINATOR
K933593 · HBI
Progressive Dynamics, Inc.
General & Plastic Surgery · 94d
Cleared Oct 28, 1993
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · JTN
Remel Co.
Microbiology · 93d
Cleared Oct 28, 1993
VENTI-GENTLE-HALER(TM)
K933915 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 79d
Cleared Oct 28, 1993
SURE-ADAPT NON-ADHERING DRESSING
K933966 · FRO
Medtrax Industries, Inc.
General & Plastic Surgery · 73d
Cleared Oct 28, 1993
BECKMAN CHOLESTEROL REAGENT
K934046 · CHH
Beckman-Diagnostic Systems Group
Chemistry · 70d
Cleared Oct 27, 1993
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · LPH
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 27, 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · LPH
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 27, 1993
COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE
K923290 · FRN
A Mixed Bag Corp.
General Hospital · 478d
Cleared Oct 27, 1993
BONE SCREWS
K923841 · HWC
Instrument Makar, Inc.
Orthopedic · 453d
Cleared Oct 27, 1993
AVITENE DISPENSER SYRINGE
K924517 · KYZ
Nusurg, Inc.
General Hospital · 418d
Cleared Oct 27, 1993
AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY
K924698 · JWH
Orthomet, Inc.
Orthopedic · 405d
Cleared Oct 27, 1993
ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR
K925328 · HWC
Anspach Mfg., Inc.
Orthopedic · 371d
Cleared Oct 27, 1993
BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
K930302 · GCI
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 279d
Cleared Oct 27, 1993
THE DE SOUTTER M193 REAMER
K930784 · HSZ
De Soutter Medical, Ltd.
Orthopedic · 253d
Cleared Oct 27, 1993
THE DE SOUTTER M182 DRILL
K930785 · HSZ
De Soutter Medical, Ltd.
Orthopedic · 253d
Cleared Oct 27, 1993
SURGICAL SUCTION TIP
K932185 · JOL
Tlc Medservices, Inc.
General Hospital · 175d