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
171193–171216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1978
CLIN. CHEM. CONTROL SERUM-QUANTITATE
K780554 · JJT
Beckman Instruments, Inc.
Chemistry · 62d
Cleared Jun 06, 1978
DISPOSABLE INFUSION SET
K780559 · FPA
Ks Medical Supply Co.
General Hospital · 62d
Cleared Jun 06, 1978
PROBE COVER
K780593 · FLL
Abco Dealers, Inc.
General Hospital · 57d
Cleared Jun 06, 1978
VELKET TOURNIQUET
K780594 · GAX
Abco Dealers, Inc.
General & Plastic Surgery · 57d
Cleared Jun 06, 1978
TREND II ANEROID
K780598 · DXN
Abco Dealers, Inc.
Cardiovascular · 57d
Cleared Jun 06, 1978
ICE BAG, VINYL
K780608 · KYR
Abco Dealers, Inc.
General Hospital · 57d
Cleared Jun 06, 1978
HALOGEN EXAM. LITE #48400
K780628 · KZF
Welch Allyn, Inc.
General Hospital · 50d
Cleared Jun 06, 1978
SUPPLEMENTAL TYGON PAC-MONITORING LINES
K780662 · FMG
Norton Performance Plastics Corp.
General Hospital · 49d
Cleared Jun 06, 1978
RECAP
K780665 · KSF
Bca Biological Corp. of America
Hematology · 46d
Cleared Jun 06, 1978
125 I-T3 UPTAKE REAGENT
K780671 · CEE
Radioimmunoassay, Inc.
Chemistry · 43d
Cleared Jun 06, 1978
125 I-T4 RIA REAGENT
K780672 · CDX
Radioimmunoassay, Inc.
Chemistry · 43d
Cleared Jun 06, 1978
PATIENT LIFT
K780684 · FSA
Orthopedic Equipment Co., Inc.
General Hospital · 43d
Cleared Jun 06, 1978
PLATELET CONTROL
K780714 · JPK
Bhp Diagnostix, Inc.
Hematology · 39d
Cleared Jun 06, 1978
CENTRIA CORTISOL RIA
K780725 · CGR
Union Carbide Corp.
Chemistry · 34d
Cleared Jun 06, 1978
LAS-R HUMAN IGE TEST
K780753 · DGC
Hyland Therapeutic Div., Travenol...
Immunology · 29d
Cleared Jun 06, 1978
KRYORACK/4
K780757 · JRR
Streck Laboratories, Inc.
Chemistry · 29d
Cleared Jun 06, 1978
NON-STERILE FOLDED GAUZE
K780764 · NAB
The Owenby Co.
General & Plastic Surgery · 33d
Cleared Jun 06, 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783 · CHH
J.T. Baker Chemical Co.
Chemistry · 25d
Cleared Jun 06, 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared Jun 06, 1978
GAUZE SPONGES
K780795 · NAB
Abco Dealers, Inc.
General & Plastic Surgery · 22d
Cleared Jun 06, 1978
ELECTRONIC THERMOMETER
K780800 · FLL
Metek Corp.
General Hospital · 22d
Cleared Jun 06, 1978
TILL-U-TEST, DIP SLIDE
K780803 · JXA
Biotron , Ltd.
Microbiology · 26d
Cleared Jun 06, 1978
S/D 600 SPHYGMOMANOMETER AND PULSEMETER
K780805 · DXN
G & W Applied Science Laboratories
Cardiovascular · 26d
Cleared Jun 02, 1978
VOLUME CONTROL DEVICE VCD-150
K780465 · KZD
Sorensen Research
Hematology · 72d