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
114841–114864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1993
CLEAN CUFF BLOOD PRESSURE CUFF LINER
K925352 · DXQ
Steridyne Corp.
Cardiovascular · 82d
Cleared Jan 12, 1993
TRACE MODEL# 840, 841,842 & 845 ARM BOARD
K925502 · KMK
Trace Medical Equipment, Inc.
General Hospital · 74d
Cleared Jan 12, 1993
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
K925533 · GBX
Angeion Corp.
General & Plastic Surgery · 71d
Cleared Jan 12, 1993
EMIT(R) II BENZODIAZEPINE ASSAY
K926067 · JXM
Syva Co.
Toxicology · 42d
Cleared Jan 12, 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · DIS
Syva Co.
Toxicology · 42d
Cleared Jan 11, 1993
TOXOGEN
K913467 · LLA
Biokit USA, Inc.
Microbiology · 525d
Cleared Jan 11, 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared Jan 11, 1993
DYNAREX SUCTION CATHETERS & KITS
K922843 · BSY
Dynarex Corp.
Anesthesiology · 213d
Cleared Jan 11, 1993
ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED
K923384 · EJJ
L.C. Dental
Dental · 228d
Cleared Jan 11, 1993
EBV-VCA IGG ELISA TEST SYSTEM
K924091 · MCD
Zeus Scientific, Inc.
Microbiology · 151d
Cleared Jan 11, 1993
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493 · JJX
Casco Standards
Chemistry · 136d
Cleared Jan 11, 1993
GAUZE SPONGES
K924650 · NAB
Dav-Mar Medical Products, Inc.
General & Plastic Surgery · 118d
Cleared Jan 11, 1993
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
K924852 · JJX
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 11, 1993
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
K924856 · JJX
Tosoh Medics, Inc.
Chemistry · 105d
Cleared Jan 11, 1993
CURITY CALCIUM ALGINATE WOUND DRESSING
K925001 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 101d
Cleared Jan 11, 1993
CFR MONOGRAPH
K925259 · EFT
Combe, Inc.
Dental · 84d
Cleared Jan 11, 1993
SOFT DENTURE RELINE MATERIAL ELASTOLINE
K925275 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 83d
Cleared Jan 11, 1993
CLEARFIL PORCELAIN BOND ACTIVATOR
K925404 · KLE
Kuraray Co.
Dental · 80d
Cleared Jan 11, 1993
DADE HEPZYME
K925452 · JBR
Baxter Diagnostics, Inc.
Hematology · 75d
Cleared Jan 11, 1993
RELIANCE SHORT STICK TIE
K925712 · DYX
Reliance Orthodontic Products, Inc.
Dental · 60d
Cleared Jan 08, 1993
CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER
K921347 · MCY
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 296d
Cleared Jan 07, 1993
DEPUY HIP PROSTHESIS
K914078 · JDI
Depuy, Inc.
Orthopedic · 484d
Cleared Jan 07, 1993
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K920082 · DQA
Biochem International, Inc.
Anesthesiology · 366d
Cleared Jan 07, 1993
TRANSDUCER, PRESSURE, CATHETER TIP
K920580 · DXO
Medamicus, Inc.
Cardiovascular · 332d