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
156385–156408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1983
EPSILON ULTRASONIC TIP
K831836 · HQC
CooperVision, Inc.
Ophthalmic · 23d
Cleared Jun 29, 1983
SUTURE KITS STERILIZED W/GAMA RADIATION
K831806 · EFQ
South Mountain Medical
General & Plastic Surgery · 26d
Cleared Jun 28, 1983
UNKNOWN
K837355
Elscint, Inc.
Radiology · 56d
Cleared Jun 28, 1983
SATURNE I LINEAR ACCELERATOR
K837412
Cgr Medical Corp.
Radiology · 68d
Cleared Jun 28, 1983
ALCYON ROTATIONAL COBALT THERAPY
K837465
Cgr Medical Corp.
Radiology · 56d
Cleared Jun 28, 1983
DENTAL CASSETTE HOLDERS
K837515
Xre Corp.
Radiology · 63d
Cleared Jun 28, 1983
SHARPLAN LASER POSITIONING SYSTEM
K837573
Laser Industries , Ltd.
Radiology · 32d
Cleared Jun 28, 1983
MV/CM2 NUMBER X74294 MODEL NUMBER 74229
K837605
Bio-Tek Instruments, Inc.
Radiology · 43d
Cleared Jun 27, 1983
SPLINTS
K831548 · ILH
Fred Sammons, Inc.
Physical Medicine · 46d
Cleared Jun 27, 1983
PIP X-RAY PROTECTIVE GLASSES
K837608
Pinnacle Intl., Inc.
Radiology · 42d
Cleared Jun 24, 1983
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
PARTIAL OSSICULAR REPLACEMENT
K823917 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
AUSTIN MODIFIED PARTIAL OSSICULAR RE-
K823918 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
TOTAL OSSICULAR REPLACEMENT
K823919 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
ISOVIS WOUND PROTECTOR
K830270 · KKX
Ritmed, Inc.
General Hospital · 150d
Cleared Jun 24, 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · JDI
Biomet, Inc.
Orthopedic · 144d
Cleared Jun 24, 1983
TPG 1000
K831002 · KQZ
Physical Diagnostics, Inc.
Orthopedic · 87d
Cleared Jun 24, 1983
SAGITTAL KNEE TESTER
K831041 · FTY
Orthopedic Systems, Inc.
General & Plastic Surgery · 85d
Cleared Jun 24, 1983
LIMITED MOTION FUNCTIONAL KNEE BRACE
K831044 · ITQ
Orthopedic Systems, Inc.
Physical Medicine · 85d
Cleared Jun 24, 1983
STRAITH ORAL AIRWAY
K831078 · CAE
Surgical Technology Laboratories, Inc.
Anesthesiology · 81d
Cleared Jun 24, 1983
SAUNDERS #7080 CERVICAL TRACTION SYS
K831135 · ILZ
Chattanooga Group, Inc.
Physical Medicine · 78d
Cleared Jun 24, 1983
CPR HEARTSAVER AND BREATHOLATOR
K831198 · BTM
Cervco Corp.
Anesthesiology · 73d
Cleared Jun 24, 1983
PATELLAR FAT PAD RETRACTOR
K831248 · HRX
Techmedica, Inc.
Orthopedic · 67d
Cleared Jun 24, 1983
TLS SURGICAL MARKER
K831372 · FZZ
Porex Medical
General & Plastic Surgery · 58d