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
133705–133728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1988
HISTO-CHECK ACID FAST SLIDES
K883568 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK GRAM NEGATIVE SLIDES
K883569 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK FUNGAL CONTROL SLIDES
K883570 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK PARASITIC CONTROL SLIDES
K883571 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
FIRST MEDIC MODE 610
K883584 · MKJ
First Medical Devices Corp.
Cardiovascular · 45d
Cleared Oct 06, 1988
MODIFIED HCG IRMA KIT
K883639 · JHI
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Oct 06, 1988
HEMOGLOBIN
K883683 · GJZ
Tech-Co, Inc.
Hematology · 38d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777 · JHI
Unipath , Ltd.
Chemistry · 30d
Cleared Oct 06, 1988
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 17d
Cleared Oct 06, 1988
SNAP N' STAIN IRON STAIN
K884011 · GGH
Scientific Device Laboratory, Inc.
Pathology · 14d
Cleared Oct 06, 1988
FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT
K884031 · KIT
Regency Biotech
Pathology · 13d
Cleared Oct 06, 1988
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · DRX
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Oct 06, 1988
ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER
K884139 · FMI
Medical Safety Products, Inc.
General Hospital · 6d
Cleared Oct 05, 1988
POLY-TAC
K882235 · LDD
Cardiovascular Group, Inc.
Cardiovascular · 131d
Cleared Oct 05, 1988
SKINCOTE
K882567 · FRO
Dynarex Corp.
General & Plastic Surgery · 105d
Cleared Oct 05, 1988
TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5
K882904 · DRX
Tdk Corp.
Cardiovascular · 85d
Cleared Oct 05, 1988
MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM
K882966 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 82d
Cleared Oct 05, 1988
BREVET DENTAL INSTRUMENTS
K883126 · EKJ
Brevet, Inc.
Dental · 71d
Cleared Oct 05, 1988
PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
K883965 · IYO
Teknar, Inc.
Radiology · 15d
Cleared Oct 04, 1988
OMRON DIGITAL FEVER THERMOMETER MODEL MC-3
K881415 · FLL
Omron Electronics, Inc.
General Hospital · 183d
Cleared Oct 04, 1988
TU STOPCOCK
K881805 · FMG
Tulan Corp. C/O Richard Hamer Assoc.
General Hospital · 159d
Cleared Oct 04, 1988
ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER
K881966 · DRF
C.R. Bard, Inc.
Cardiovascular · 146d
Cleared Oct 04, 1988
MEDICAL GLOVES STERILE LATEX SURGEONS DIGIFORM
K882595 · KGO
Marathon Management Co.
General Hospital · 102d
Cleared Oct 04, 1988
NON-CORING NEEDLES
K883009 · FMI
Quinton, Inc.
General Hospital · 77d