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
97033–97056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1996
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
K960726 · HGX
Evenflo Co., Inc.
Obstetrics & Gynecology · 151d
Cleared Jul 22, 1996
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · GKZ
Coulter Corp.
Hematology · 110d
Cleared Jul 22, 1996
PORT-A-POLE
K961470 · FOX
Prins Medical Ind., Inc.
General Hospital · 96d
Cleared Jul 22, 1996
ELECSYS TSH ASSAY
K961491 · JLW
Boehringer Mannheim Corp.
Chemistry · 95d
Cleared Jul 22, 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · JJY
Casco Standards
Chemistry · 77d
Cleared Jul 22, 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 22, 1996
BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE
K962130 · DZE
Nobelpharma USA, Inc.
Dental · 49d
Cleared Jul 22, 1996
MUCUS SPECIMEN TRAP
K962168 · KDQ
Sage Products, Inc.
General Hospital · 47d
Cleared Jul 22, 1996
FIBER-SPLINT ML MULTILAYER
K962374 · EBI
Polydentia USA
Dental · 32d
Cleared Jul 22, 1996
DRYTIME FOR BLADDER CONTROL SILENT
K962416 · KPN
Bio-Systems Research
Gastroenterology & Urology · 83d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL TSH
K962573 · JJX
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 22, 1996
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
K962574 · LEQ
Waters Corporation
Toxicology · 21d
Cleared Jul 22, 1996
ELECSYS PRECICONTROL CARDIAC
K962575 · JJY
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Jul 22, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630 · JJY
Casco Standards
Chemistry · 17d
Cleared Jul 22, 1996
OPUS B12 CONTROLS
K962694 · JJX
Behring Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 19, 1996
DIOPEXY PROBE
K960522 · HQF
Iriderm Div.
Ophthalmic · 164d
Cleared Jul 19, 1996
SENTINEL LIPASE LIQUID MODEL 17.401B
K961179 · CHI
Equal Diagnostics, Inc.
Chemistry · 115d
Cleared Jul 19, 1996
3D SCOPE
K961182 · GCJ
Oktas
General & Plastic Surgery · 115d
Cleared Jul 19, 1996
ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
K961264 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 108d
Cleared Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615 · LJT
Arrow Intl., Inc.
General Hospital · 84d
Cleared Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · LJT
Arrow Intl., Inc.
General Hospital · 80d
Cleared Jul 19, 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727 · LZO
Intermedics Orthopedics
Orthopedic · 77d
Cleared Jul 19, 1996
MEDCARE SUCTION CONNECTING TUBING
K961880 · GCX
Medcare Medical Group, Inc.
General Hospital · 65d
Cleared Jul 19, 1996
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959 · GAA
Medical Device Technologies, Inc.
General & Plastic Surgery · 60d