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
82873–82896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2000
ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
K000232 · JWH
Corin USA
Orthopedic · 29d
Cleared Feb 25, 2000
EBI XFIX DFS SYSTEM
K000319 · KTT
Ebi, L.P.
Orthopedic · 23d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335 · LPH
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 25, 2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA...
K000430 · DTZ
Medtronic Vascular
Cardiovascular · 16d
Cleared Feb 25, 2000
ONEFLOW
K980951 · BZH
Sti Medical
Anesthesiology · 714d
Cleared Feb 25, 2000
MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE
K991329 · MQL
Medicult A/S
Obstetrics & Gynecology · 312d
Cleared Feb 25, 2000
MEDI-CULT LIQUID PARAFFIN
K991330 · MQL
Medicult A/S
Obstetrics & Gynecology · 312d
Cleared Feb 25, 2000
OVOIL-150, MODEL 5002
K991351 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 312d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220 · KWI
Smith & Nephew, Inc.
Orthopedic · 239d
Cleared Feb 25, 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · FMF
Shinchang Medical Co., Ltd.
General Hospital · 170d
Cleared Feb 25, 2000
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3...
K993515 · FOZ
Medefil, Inc.
General Hospital · 130d
Cleared Feb 25, 2000
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · JDR
Biomedical Ent., Inc.
Orthopedic · 115d
Cleared Feb 25, 2000
CLEEN-ABLE
K994044 · DXQ
Vital Signs, Inc.
Cardiovascular · 88d
Cleared Feb 25, 2000
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · KXA
Corin USA
Orthopedic · 79d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS...
K994202 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Feb 24, 2000
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
K000034 · IYN
Optimal Imaging Systems, Inc.
Radiology · 49d
Cleared Feb 24, 2000
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
K000056 · JJX
Biocell Laboratories, Inc.
Chemistry · 48d
Cleared Feb 24, 2000
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · IKN
Motion Lab Systems, Inc.
Neurology · 31d
Cleared Feb 24, 2000
MERETEK UBT_LITE BREATH TEST FOR H. PYLORI
K000316 · MSQ
Meretek
Microbiology · 23d
Cleared Feb 24, 2000
E.N.S.I. SYRINGE
K000572 · MEG
Tri-Ject Intl. Corp.
General Hospital · 2d
Cleared Feb 24, 2000
PH-100, MODEL 2104
K991346 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 311d
Cleared Feb 24, 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · MWI
Critikon Company, LLC
Cardiovascular · 202d
Cleared Feb 24, 2000
DEFINITE
K993514 · EBF
Degussa - Ney Dental, Inc.
Dental · 129d