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
121585–121608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1991
ROCHE REAGENT FOR APOLIPOPROTEIN B
K910552 · MSJ
Roche Diagnostic Systems, Inc.
Immunology · 89d
Cleared May 07, 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · DTC
Medtronic Vascular
Cardiovascular · 84d
Cleared May 07, 1991
CARDIOCAP DR-124 RECORDER
K910620 · DRG
Datex Division Instrumentarium Corp.
Cardiovascular · 84d
Cleared May 07, 1991
DISPOSABLE PATIENT CABLE
K910645 · DSA
Diag Corp.
Cardiovascular · 83d
Cleared May 07, 1991
GENESIS I AUTOMATED CELL COUNTER
K910679 · GKL
Alicia Diagnostics, Inc.
Hematology · 81d
Cleared May 07, 1991
DISPOSABLE RETRACTABLE NEEDLE SYRINGE
K910731 · FMF
Safe Tech Medical Products, Inc.
General Hospital · 76d
Cleared May 07, 1991
MET-ETCH
K910813 · EBC
Gresco Products, Inc.
Dental · 70d
Cleared May 07, 1991
QBC AUTOREADER
K910834 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared May 07, 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · DYB
Daig Corp.
Cardiovascular · 81d
Cleared May 07, 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · DRF
C.R. Bard, Inc.
Cardiovascular · 54d
Cleared May 07, 1991
MODIFIED PK TP CONTROL
K911266 · GMT
Olympus Corp.
Microbiology · 53d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared May 07, 1991
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SM ANTIBODY TEST
K911851 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared May 06, 1991
GLOBALCARE MICRO 11 AND MICROCARE (TENS)
K903394 · GZJ
Globalcare Intl., Inc.
Neurology · 283d
Cleared May 06, 1991
OLYMPUS PK-TP ABSORBENT KIT
K905038 · GMT
Fujirebio America, Inc.
Microbiology · 181d
Cleared May 06, 1991
SPIROSCOPE
K905480 · BZC
Grandcor Medical Systems
Anesthesiology · 151d
Cleared May 06, 1991
FHT (FECAL HEME TEST)
K905782 · KHE
Aerscher, Inc.
Hematology · 136d
Cleared May 06, 1991
PTI STERNAL CLOSURE WIRE SUTURE
K910067 · GAQ
Pioneering Technologies, Inc.
General & Plastic Surgery · 117d
Cleared May 06, 1991
CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.
K910496 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1991
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
K910500 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared May 06, 1991
FREEDOM MARK III SURGICAL HELMET SYSTEM
K910515 · FYA
Stackhouse Assoc.
General Hospital · 90d