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
90553–90576 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · MNH
United States Surgical, A Division of...
Orthopedic · 82d
Cleared Mar 10, 1998
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL
K974781 · HSB
Depuy, Inc.
Orthopedic · 78d
Cleared Mar 10, 1998
OUTLOOK SYSTEM ENHANCEMENT PACKAGE
K974844 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 76d
Cleared Mar 10, 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · CFR
Trace America, Inc.
Chemistry · 64d
Cleared Mar 10, 1998
HEAT STACK
K980086 · LGZ
Medical Solutions, Inc.
General Hospital · 60d
Cleared Mar 10, 1998
EPILASER I UPGRADE KIT
K980160 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 53d
Cleared Mar 09, 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
K973916 · FPA
Np Medical, Inc.
General Hospital · 146d
Cleared Mar 09, 1998
SYNERGY
K974465 · EBF
Coltene/Whaledent, Inc.
Dental · 103d
Cleared Mar 09, 1998
H2O
K974587 · OLV
Grass-Telefactor Product Group
Neurology · 90d
Cleared Mar 09, 1998
ADC COMPACT (AGFA DIAGNOSTIC CENTER)
K974597 · KPR
Bayer Corp., Agfa Div.
Radiology · 90d
Cleared Mar 09, 1998
DAUM NEUROBIOPSY NEEDLE
K974631 · KNW
Daum Corp.
Gastroenterology & Urology · 87d
Cleared Mar 09, 1998
PERSYST PRISM
K974718 · GWS
Persyst Development Corp.
Neurology · 82d
Cleared Mar 09, 1998
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K974758 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K974759 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
K974789 · GEX
Lumenis, Inc.
General & Plastic Surgery · 77d
Cleared Mar 09, 1998
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K980022 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 63d
Cleared Mar 09, 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · FRN
Smith & Nephew, Inc.
General Hospital · 59d
Cleared Mar 09, 1998
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
K980123 · GCJ
Louisville Laboratories, Inc.
General & Plastic Surgery · 54d
Cleared Mar 09, 1998
FLOWABLE HYBRID
K980298 · EBD
Cosmedent, Inc.
Dental · 41d
Cleared Mar 09, 1998
NON-WOVEN COMPRESS
K980382 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 35d
Cleared Mar 09, 1998
CARRARA PDF, CARRARA H, CARRARA R
K980597 · EJT
European Dental Imports, Inc.
Dental · 20d
Cleared Mar 09, 1998
PROGOLD ELECTROCOPING SYSTEM
K980613 · EJT
Micro Dental Laboratories
Dental · 19d
Cleared Mar 06, 1998
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
K972511 · DXE
Microvena Corp.
Cardiovascular · 246d
Cleared Mar 06, 1998
RANDOX CREATININE
K973993 · CGX
Randox Laboratories, Ltd.
Chemistry · 136d