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
134617–134640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1988
DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER
K881080 · LYG
Ferguson Medical
Physical Medicine · 129d
Cleared Jul 21, 1988
DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER
K881081 · LYG
Ferguson Medical
Physical Medicine · 129d
Cleared Jul 21, 1988
AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
K881142 · CGJ
Amersham Corp.
Chemistry · 126d
Cleared Jul 21, 1988
DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER
K881245 · EBI
Cadco Dental Products, Inc.
Dental · 120d
Cleared Jul 21, 1988
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
K881284 · JFC
Nathaniel Gould Diagnostics, Inc.
Physical Medicine · 118d
Cleared Jul 21, 1988
REAGENTS FOR TSH ASSAY
K881381 · JLW
Sclavo, Inc.
Chemistry · 111d
Cleared Jul 21, 1988
RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
K881931 · CBP
Rondex Products, Inc.
Anesthesiology · 73d
Cleared Jul 21, 1988
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
K882259 · JIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 51d
Cleared Jul 21, 1988
A.X.T. SPOTFILM DEVICE
K882492 · IXL
Applied X-Ray Technologies, Inc.
Radiology · 35d
Cleared Jul 21, 1988
LATEX EXAMINATION GLOVE
K882533 · FMC
Sukas Export
General Hospital · 30d
Cleared Jul 21, 1988
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · JJY
Bio-Rad
Chemistry · 30d
Cleared Jul 21, 1988
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · FCG
Acuson Corp.
Gastroenterology & Urology · 31d
Cleared Jul 21, 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · CCW
Augustine Medical, Inc.
Anesthesiology · 23d
Cleared Jul 20, 1988
ORMON DIGITAL FEVER THERMOMETER MODEL MC-3B
K881446 · FLL
Ormon Electronics, Inc.
General Hospital · 105d
Cleared Jul 20, 1988
JIMMY JOHN III
K881720 · KPL
Colon Therapeutics
Gastroenterology & Urology · 90d
Cleared Jul 20, 1988
MODEL 20 KY KRYPTON YELLOW LASER
K881940 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jul 20, 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · DRX
Lectec Corp.
Cardiovascular · 55d
Cleared Jul 19, 1988
MULTIPURPOSE TRANSDUCER RANGE
K874192 · IYO
Pie Data Medical BV
Radiology · 279d
Cleared Jul 19, 1988
IONODENT (TOOTHBRUSH)
K874443 · EFW
U.S. Apatite Corp.
Dental · 265d
Cleared Jul 19, 1988
SORBSAN TOPICAL WOUND DRESSING
K881854 · FRO
E.G. Dick & Assoc.
General & Plastic Surgery · 77d
Cleared Jul 19, 1988
C-E BRUSH
K881921 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 71d
Cleared Jul 19, 1988
PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP
K881982 · JWH
Howmedica Corp.
Orthopedic · 68d
Cleared Jul 19, 1988
HEADREST, PATIENT COMFORT
K882332 · KME
Surgic Aid, Inc.
General Hospital · 43d
Cleared Jul 19, 1988
ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE
K882493 · FOX
Cambridge Technologies, Inc.
General Hospital · 33d