FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83377–83400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · DWZ
Boston Scientific Corp
Cardiovascular · 20d
Cleared Feb 28, 2000
MEDI-CULT SPERM FREEZE MEDIUM
K991333 · MQL
Medicult A/S
Obstetrics & Gynecology · 315d
Cleared Feb 28, 2000
MEDI-CULT FREEZING & THAWING PACKS
K991335 · MQL
Medicult A/S
Obstetrics & Gynecology · 315d
Cleared Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147 · MNI
Advanced Spine Technology, Inc.
Orthopedic · 249d
Cleared Feb 28, 2000
NEURO URODYNAMIC SUITE, MODEL 9032E0101
K992715 · FEN
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 200d
Cleared Feb 28, 2000
ZOLL M SERIES ETCO2 OPTION
K993036 · MKJ
Zoll Medical Corp
Cardiovascular · 172d
Cleared Feb 28, 2000
DRYSPOT E.COLI 0157 KIT
K993401 · GNA
Oxoid , Ltd.
Microbiology · 143d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · MNH
Blackstone Medical, Inc.
Orthopedic · 75d
Cleared Feb 28, 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · MQF
Rocket Medical Plc
Obstetrics & Gynecology · 68d
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