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
138601–138624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1987
MINIMUM ESSENTIAL MEDIUM EAGLE(MEM) CAT.#200-2115
K873025 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 19, 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K873026 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 19, 1987
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM)CAT. #200-2045
K873027 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 19, 1987
MINIMUM ESSENTIAL MEDIUM EAGLE(MEM ALPHA MODIFICA)
K873028 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 19, 1987
CONTROLCHEK II(TM)
K873034 · JTO
Petra Biomedical Products, Inc.
Microbiology · 14d
Cleared Aug 18, 1987
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
K865098 · DTB
Telectronics, Inc.
Cardiovascular · 231d
Cleared Aug 18, 1987
DYNATRON 500
K870947 · IPF
Dynatronics Corp.
Physical Medicine · 162d
Cleared Aug 18, 1987
CASANDRA SYRINGE CAP
K871443 · FMF
Casandra Medical Corp.
General Hospital · 127d
Cleared Aug 18, 1987
APEX ALPHA VACUUM PUMP
K871570 · BTA
Apex Medical, Inc.
General & Plastic Surgery · 118d
Cleared Aug 18, 1987
ABBOTT BIOTELL PREGNANCY TEST
K871996 · LCX
Abbott Laboratories
Chemistry · 84d
Cleared Aug 18, 1987
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025 · KWL
Depuy, Inc.
Orthopedic · 84d
Cleared Aug 18, 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
K872306 · CIC
Boehringer Mannheim Corp.
Chemistry · 64d
Cleared Aug 17, 1987
ZINDRICK IM ROD
K871539 · HSB
Buckman Co., Inc.
Orthopedic · 119d
Cleared Aug 17, 1987
OLYMPUS GF-UM2/EU-M2
K872027 · IYO
Olympus Corp.
Radiology · 83d
Cleared Aug 17, 1987
IMMUBEAD THYROID UPTAKE
K872172 · KHQ
Immunotech Corp.
Chemistry · 70d
Cleared Aug 17, 1987
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS
K872214 · GEA
CooperVision, Inc.
General & Plastic Surgery · 69d
Cleared Aug 17, 1987
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · KTT
Howmedica Corp.
Orthopedic · 69d
Cleared Aug 17, 1987
AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE
K872366 · BTR
Bivona Medical Technologies
Anesthesiology · 60d
Cleared Aug 17, 1987
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · LFW
Innotron of Oregon, Inc.
Chemistry · 54d
Cleared Aug 17, 1987
INNOFLUOR VANCOMYCIN REAGENT SET
K872579 · LEH
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Aug 17, 1987
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845 · DHN
Bion Ent., Ltd.
Immunology · 28d
Cleared Aug 17, 1987
BIOPRO 32MM BALL
K872856 · JDI
Biopro, Inc.
Orthopedic · 27d
Cleared Aug 17, 1987
ACE CANCELLOUS BONE SCREW
K872859 · HWC
Ace Medical Co.
Orthopedic · 27d
Cleared Aug 17, 1987
TRIGLYCERIDE (UV) REAGENT
K872912 · JGW
Sigma Chemical Co.
Chemistry · 24d